Recall events
/
Event 72992
Event summary
Timeline bucket January 07, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Customed, Inc
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
100 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Recall number Z-1397-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 540
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1397-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38241]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15215 (150719671) 31-JUL-16 SL15222 (150719671) 31-JUL-16 SL15246 (150820227) 31-AUG-16 SL15252 (150820227) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17715]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1398-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 9000
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1398-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3025]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18701]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1399-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 32
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1399-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38243]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18459]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1400-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 4400
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1400-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24690]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19072]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1401-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 60
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1401-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8992]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22845]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1402-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 900
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1402-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32301]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22908]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1403-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 132
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1403-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8995]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150418257) 30-APR-16 SL15170 (150418258) 30-APR-16 SL15181 (150619549) 30-JUN-16 SL15181 (150619548) 30-JUN-16 SL15199 (150719611) 31-JUL-16 SL15215 (150719612) 31-JUL-16 SL15216 (150719612) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19067]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1404-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 40
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1404-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8996]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150619101) 30-JUN-16 SL15202 (150719613) 31-JUL-16 SL15245 (150820662) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22939]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1405-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 4550
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1405-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14879]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150317576) 28-FEB-16 SL15169 (150619102) 31-MAY-16 SL15169 (150518600) 31-MAY-16 SL15170 (150518600) 31-MAY-16 SL15173 (150619102) 31-MAY-16 SL15175 (150418229) 31-MAY-16 SL15199 (150719614) 31-MAY-16 SL15203 (150719614) 31-MAY-16 SL15225 (150719614) 31-MAY-16 SL15231 (150820140) 31-AUG-16 SL15243 (150820140) 31-AUG-16 SL15251 (150820140) 31-AUG-16 SL15272 (150920663) 30-SEP-16 SL15273 (150920663) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23873]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1406-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 600
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1406-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14875]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619313) 31-MAY-16 SL15174 (150619313) 31-MAY-16 SL15197 (150719820) 31-JUL-16 SL15202 (150719820) 31-JUL-16 SL15208 (150719820) 31-JUL-16 SL15274 (150920664) 30-SEP-16 SL15274 (150920144) 30-SEP-16 SL15275 (150920664) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19443]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1407-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 140
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1407-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55946]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15187 (150619473) 30-JUN-16 SL15197 (150719616) 31-JUL-16 SL15240 (150820571) 31-AUG-16 SL15251 (150920666) 30-SEP-16 SL15259 (150920926) 30-SEP-16 SL15259 (150920925) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17765]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1408-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1408-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50021]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15194 (150719821) 31-JUL-16 SL15243 (150820582) 31-AUG-16 SL15274 (150920674) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19407]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1409-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1409-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38244]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150719822) 31-JUL-16 SL15203 (150719822) 31-JUL-16 SL15215 (150720063) 31-JUL-16 SL15216 (150720063) 31-JUL-16 SL15244 (150820583) 31-AUG-16 SL15246 (150820583) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19122]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1410-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 80
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1410-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32315]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150719622) 31-JUL-16 SL15211 (150720064) 31-JUL-16 SL15212 (150720065) 31-JUL-16 SL15245 (150820677) 31-AUG-16 SL15245 (150820676) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19378]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1411-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 2800
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1411-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14881]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18426]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1412-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 2920
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1412-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[93]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15183 (150619119) 30-JUN-16 SL15184 (150619119) 30-JUN-16 SL15187 (150619119) 30-JUN-16 SL15212 (150719823) 31-JUL-16 SL15215 (150719823) 31-JUL-16 SL15216 (150719823) 31-JUL-16 SL15217 (150720152) 31-JUL-16 SL15217 (150719823) 31-JUL-16 SL15219 (150719823) 31-JUL-16 SL15219 (150720152) 31-JUL-16 SL15223 (150720152) 31-JUL-16 SL15224 (150720152) 31-JUL-16 SL15225 (150719823) 31-JUL-16 SL15252 (150820683 31-AUG-16 SL15254 (150820683) 31-AUG-16 SL15257 (150820683) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23885]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1413-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 380
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1413-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[53049]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15194 (150719924) 31-JUL-16 SL15210 (150719924) 31-JUL-16 SL15216 (150719925) 31-JUL-16 SL15218 (150719925) 31-JUL-16 SL15222 (150719824) 31-JUL-16 SL15224 (150719824) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19083]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1414-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 2088
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1414-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32300]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15195-01 (150719825) 31-JUL-16 SL15195-02 (150719825) 31-JUL-16 SL15197 (150719825) 31-JUL-16 SL15218 (150719825) 31-JUL-16 SL15232 (150820156) 31-AUG-16 SL15233 (150820156) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19130]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1415-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 1020
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1415-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14877]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SV15168 (150518595) 31-MAY-16 SL15223 (150719827) 31-JUL-16 SL15224 (150719827) 31-JUL-16 SL15225 (150719827) 31-JUL-16 SL15245 (150820633) 31-AUG-16 SL15246 (150820633) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23926]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1416-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 42
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1416-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20925]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15208 (150719625) 31-JUL-16 SL15209 (150719625) 31-JUL-16 SL15217 (150720066) 31-JUL-16 SL15267 (150920686) 30-SEP-16 SL15271 (150920686) 30-SEP-16 SL15272 (150920686) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19397]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1417-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 45
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1417-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8997]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150719828) 31-JUL-16 SL15203 (150719828) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17729]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1418-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 258
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1418-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14874]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24892]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1419-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 220
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1419-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32302]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22924]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1420-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 85
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1420-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38235]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15195-02 (150719829) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18490]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1421-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 81
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1421-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24695]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24829]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1422-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 15
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1422-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38242]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15175 (150619485) 30-JUN-16 SL15225 (150719857) 31-AUG-16 SL15230 (150820074) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17785]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1423-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 40
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1423-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38239]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (140814647) 30-JUN-16 SL15202 (150719858) 31-JUL-16 SL15225 (150820446) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19048]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1424-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 200
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1424-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32299]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15197 (150719929) 30-APR-16 SL15201-01 (150719929) 30-APR-16 SL15218 (150719929) 30-APR-16 SL15266 (150920778) 31-MAY-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18632]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1425-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 35
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1425-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55950]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150619550) 30-JUN-16 SL15202 (150619235) 30-JUN-16 SL15209 (150719642) 31-JUL-16 SL15209 (150619550) 30-JUN-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18480]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1426-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 70
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1426-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44190]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15201-01 (150719645) 31-JUL-16 SL15222 (150719959) 30-JUN-16 SL15223 (150719959) 30-JUN-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22801]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1427-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 12
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1427-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55988]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15181 (150619167) 30-JUN-16 SL15181 (150619386) 30-JUN-16 SL15209 (150619386) 30-JUN-16 SL15209 (150719646) 31-JUL-16 SL15224 (150820077) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18473]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1428-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 24
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1428-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24689]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15173 (150619387) 30-JUN-16 SL15174 (150619387) 30-JUN-16 SL15194 (150719649) 31-JUL-16 SL15211 (150720078) 31-JUL-16 SL15211 (150720079) 31-JUL-16 SL15273 (150920693) 30-SEP-16 SL15275 (150920693) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22885]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1429-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 550
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1429-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50023]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619169) 31-MAY-16 SL15187 (150619170) 31-MAY-16 SL15201-01 (150719651) 31-MAY-16 SL15201-01 (150719650) 31-MAY-16 SL15233 (150820175) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18438]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1430-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 270
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1430-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44195]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15194 (150719656) 31-JUL-16 SL15223 (150820181) 31-AUG-16 SL15223 (150820180) 31-AUG-16 SL15223 (150820182) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19134]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1431-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 55
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1431-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55941]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619358) 30-JUN-16 SL15191-01 (150619359) 31-JUL-16 SL15211 (150719661) 31-JUL-16 SL15217 (150719661) 31-JUL-16 SL15245 (150720128) 31-AUG-16 SL15245 (150720127) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19437]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1432-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 15
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1432-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20924]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15244 (150820587) 30-JUN-16 SL15245 (150820587) 30-JUN-16 SL15251 (150719662) 30-JUN-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17805]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1433-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 9
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1433-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20923]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19142]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1434-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 25
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1434-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55956]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOT: SL15209 (150719960) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23946]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1435-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 938
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1435-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44193]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23891]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1436-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 3700
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1436-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50025]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15199 (150719930) 31-JUL-16 SL15203 (150719930) 31-JUL-16 SL15232 (150820226) 31-AUG-16 SL15268 (150920789) 30-SEP-16 SL15243 (150820226) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17746]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1437-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 540
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1437-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44183]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15215 (150719671) 31-JUL-16 SL15222 (150719671) 31-JUL-16 SL15246 (150820227) 31-AUG-16 SL15252 (150820227) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22898]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1438-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 168
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1438-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55942]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150518594) 30-JUN-16 SL15170 (150518592) 30-JUN-16 SL15199 (150719720) 30-JUN-16 SL15199 (150719719) 30-JUN-16 SL15203 (150719720) 30-JUN-16 SL15230 (150819721) 30-JUN-16 SL15231 (150819722) 30-JUN-16 SL15231 (150820230) 30-JUN-16 SL15243 (150820231) 30-JUN-16 SL15243 (150820229) 30-JUN-16 SL15259 (150920791) 30-JUN-16 SL15259 (150920917) 30-JUN-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19079]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1439-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 168
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1439-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9000]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15176 (150619390) 30-JUN-16 SL15231 (150819833) 31-AUG-16 SL15233 (150619391) 31-AUG-16 SL15240 (150819834) 31-AUG-16 SL15259 (150920237) 30-SEP-16 SL15259 (150920236) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18699]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1440-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 20
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1440-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20920]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15195-01 (150619229) 31-JUL-16 SL15210 (150619392) 31-JUL-16 SL15211 (150619392) 31-JUL-16 SL15223 (150719733) 31-AUG-16 SL15224 (150719733) 31-AUG-16 SL15275 (150920795) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24835]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1441-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 12
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1441-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24694]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS:SL15177 (150619394) 30-JUN-16 SL15181 (150619394) 30-JUN-16 SL15203 (150719752) 31-JUL-16 SL15223 (150820261) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17758]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1442-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 24
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1442-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3022]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619249) 30-JUN-16 SL15174 (150619249) 30-JUN-16 SL15184 (150619395) 30-JUN-16 SL15210 (150719753) 31-JUL-16 SL15210 (150619395) 30-JUN-16 SL15273 (150920799) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17792]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1443-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 150
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1443-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24692]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619250) 30-JUN-16 SL15180 (150619397) 30-JUN-16 SL15180 (150619396) 30-JUN-16 SL15180 (150619250) 30-JUN-16 SL15202 (150719754) 31-JUL-16 SL15225 (150820263) 31-AUG-16 SL15225 (150820262) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17705]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1444-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 42
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1444-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3020]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15229 (150719755) 31-AUG-16 SL15230 (150719755) 31-AUG-16 SL15231 (150719755) 31-AUG-16 SL15240 (150719755) 31-AUG-16 SL15260 (150820264) 30-SEP-16 SL15260 (150820265) 30-SEP-16 SL15261 (150820264) 30-SEP-16 SL15272 (150820264) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19171]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1445-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 280
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1445-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3027]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150519027) 30-JUN-16 SL15191-01 (150519026) 30-JUN-16 SL15211 (150719756) 31-JUL-16 SL15229 (150820266) 31-AUG-16 SL15258 (150920880) 30-SEP-16 SL15258 (150920802) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22917]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1446-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 24
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1446-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55945]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15201-02 (150619399) 30-JUN-16 SL15203 (150619399) 30-JUN-16 SL15210 (150719862) 31-JUL-16 SL15260 (150820588) 30-SEP-16 SL15261 (150820588) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17736]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1447-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 84
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1447-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32296]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15173 (150418356) 31-MAY-16 SL15195-01 (150619256) 30-JUN-16 SL15199 (150619256) 30-JUN-16 SL15208 (150719758) 31-JUL-16 SL15212 (150719758) 31-JUL-16 SL15224 (150719758) 31-JUL-16 SL15243 (150820288) 31-AUG-16 SL15260 (150920289) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22826]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1448-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1448-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24682]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15181 (150619410) 30-JUN-16 SL15184 (150619410) 30-JUN-16 SL15223 (150820284) 31-AUG-16 SL15223 (150820283) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19165]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1449-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 90
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1449-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8993]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15201-02 (150719840) 31-JUL-16 SL15259 (150920293) 30-SEP-16 SL15259 (150920294) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19162]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1450-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 344
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1450-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24693]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150317841) 30-APR-16 SL15170 (150317843) 30-APR-16 SL15180 (150619260) 30-JUN-16 SL15184 (150317844) 30-APR-16 SL15199 (150719841) 31-JUL-16 SL15203 (150719841) 31-JUL-16 SL15229 (150820295) 31-AUG-16 SL15245 (150820296) 31-AUG-16 SL15246 (150820296) 31-AUG-16 SL15267 (150920885) 31-AUG-16 SL15268 (150920886) 31-AUG-16 SL15271 (150920887) 31-AUG-16 SL15273 (150920884) 31-AUG-16 SL15273 (150920809) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19423]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1451-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 76
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1451-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55951]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15203 (150719261) 31-JUL-16 SL15203 (150719842) 31-JUL-16 SL15211 (150719261) 31-JUL-16 SL15211 (150719842) 31-JUL-16 SL15244 (150820297) 31-AUG-16 SL15245 (150820297) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19375]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1452-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 18
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1452-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55986]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22864]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1453-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 18
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1453-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32320]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19462]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1454-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 136
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1454-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44192]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15181 (150619402) 30-JUN-16 SL15184 (150619402) 30-JUN-16 SL15184 (150619265) 30-JUN-16 SL15274 (150820300) 30-SEP-16 SL15275 (150820301) 30-SEP-16 SL15275 (150820300) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24757]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1455-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 47
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1455-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24676]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619477) 30-JUN-16 SL15181 (150619477) 30-JUN-16 SL15212 (150719843) 31-JUL-16 SL15215 (150719843) 31-JUL-16 SL15219 (150719843) 31-JUL-16 SL15271 (150920812) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23863]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1456-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 24
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1456-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3021]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15201-02 (150619403) 31-JUL-16 SL15201-02 (150619266) 31-JUL-16 SL15202 (150619403) 31-JUL-16 SL15208 (150619403) 31-JUL-16 SL15232 (150820302) 31-AUG-16 SL15243 (150820302) 31-AUG-16 SL15246 (150820303) 31-AUG-16 SL15251 (150820303) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22862]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1457-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 39
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1457-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8999]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15184 (150518788) 30-JUN-16 SL15210 (150719844) 31-JUL-16 SL15212 (150719844) 31-JUL-16 SL15243 (150820304) 31-AUG-16 SL15244 (150820304) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17770]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1458-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 5650
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1458-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55952]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15175 (150518789) 30-APR-16 SL15177 (150518789) 30-APR-16 SL15180 (150619314) 30-APR-16 SL15183 (150619314) 30-APR-16 SL15232 (150820305) 31-MAY-16 SL15233 (150820305) 31-MAY-16 SL15233 (150719845) 31-MAY-16 SL15243 (150719845) 31-MAY-16 SL15268 (150920814) 31-MAY-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19179]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1459-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 2450
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1459-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[41281]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SV15168 (150217396) 28-FEB-16 SL15201-02 (150719848) 31-JUL-16 SL15208 (150719848) 31-JUL-16 SL15229 (150820306) 31-AUG-16 SL15231 (150820306) 31-AUG-16 SL15265 (150920815) 31-AUG-16 SL15266 (150920815) 31-AUG-16 SL15267 (150920815) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18692]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1460-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 597
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1460-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14883]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15194 (150719776) 31-JUL-16 SL15197 (150719778) 31-JUL-16 SL15199 (150719777) 31-JUL-16 SL15201-01 (150719777) 31-JUL-16 SL15217 (150720038) 31-AUG-16 SL15219 (150720039) 31-AUG-16 SL15222 (150720039) 31-AUG-16 SL15222 (150720038) 31-AUG-16 SL15225 (150720040) 31-AUG-16 SL15231 (150720040) 31-AUG-16 SL15271 (150920908) 30-SEP-16 SL15271 (150920640) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19107]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1461-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 152
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1461-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44189]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15187 (150719782) 31-JUL-16 SL15191-01 (150719783) 31-JUL-16 SL15244 (150820308) 31-AUG-16 SL15264 (150820309) 30-SEP-16 SL15273 (150820307) 30-SEP-16 SL15274 (150820307) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24842]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1462-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 85
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1462-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20930]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15187 (150619316) 30-JUN-16 SL15195-01 (150719785) 31-JUL-16 SL15265 (150820310) 30-SEP-16 SL15271 (150820311) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19057]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1463-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 72
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1463-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8994]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15174 (150518912) 30-JUN-16 SL15240 (150820312) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19394]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1464-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 304
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1464-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50033]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15197 (150719792) 31-JUL-16 SL15208 (150719793) 31-JUL-16 SL15216 (150719793) 31-JUL-16 SL15225 (150820315) 31-AUG-16 SL15225 (150820314) 31-AUG-16 SL15230 (150820315) 31-AUG-16 SL15243 (150719793) 31-JUL-16 SL15272 (150920895) 30-SEP-16 SL15272 (150920819) 30-SEP-16 SL15272 (150920897) 30-SEP-16 SL15272 (150920896) 30-SEP-16 SL15273 (150920897) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17843]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1465-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 96
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1465-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50028]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19059]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1466-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 55
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1466-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55943]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15203 (150719872) 31-JUL-16 SL15225 (150820317) 31-AUG-16 SL15274 (150920821) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22854]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1467-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 48
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1467-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50019]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15176 (150619271) 30-JUN-16 SL15177 (150619271) 30-JUN-16 SL15181 (150619271) 30-JUN-16 SL15201-01 (150719797) 31-JUL-16 SL15217 (150720129) 31-JUL-16 SL15217 (150720130) 31-JUL-16 SL15219 (150720131) 31-JUL-16 SL15219 (150720130) 31-JUL-16 SL15223 (150720129) 31-JUL-16 SL15224 (150720131) 31-JUL-16 SL15268 (150920822) 30-SEP-16 SL15271 (150920822) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17829]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1468-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 96
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1468-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50032]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619275) 30-JUN-16 SL15233 (150719849) 31-JUL-16 SL15240 (150719849) 31-JUL-16 SL15264 (150820590) 30-SEP-16 SL15264 (150920589) 30-SEP-16 SL15266 (150820590) 30-SEP-16 SL15274 (150920824) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19100]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1469-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 44
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1469-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32295]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15180 (150619283) 30-JUN-16 SL15194 (150719803) 31-JUL-16 SL15243 (150820325) 31-AUG-16 SL15243 (150820324) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19448]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1470-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 110
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1470-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38238]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150418502) 30-APR-16 SL15173 (150619371) 30-JUN-16 SL15180 (150619553) 30-JUN-16 SL15180 (150619552) 30-JUN-16 SL15184 (150619553) 30-JUN-16 SL15195-01 (150719884) 31-JUL-16 SL15195-02 (150719884) 31-JUL-16 SL15197 (150719884) 31-JUL-16 SL15265 (150920827) 30-SEP-16 SL15273 (150920592) 30-SEP-16 SL15274 (150920592) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22963]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1471-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 120
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1471-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38245]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619284) 30-APR-16 SL15173 (150619372) 30-JUN-16 SL15195-02 (150619554) 30-JUN-16 SL15195-02 (150719804) 30-APR-16 SL15264 (150820330) 31-AUG-16 SL15274 (150920828) 31-AUG-16 SL15275 (150920828) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19113]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1472-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1472-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32314]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15203 (150719885) 31-JUL-16 SL15271 (150920829) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19412]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1473-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 60
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1473-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44185]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15203 (150719886) 31-JUL-16 SL15243 (150820332) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18647]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1474-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 5712
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1474-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3024]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SV15168 (150418240) 30-APR-16 SL15209 (150719850) 31-JUL-16 SL15218 (150719850) 31-JUL-16 SL15229 (150719850) 31-JUL-16 SL15244 (150820336) 31-AUG-16 SL15251 (150719850) 31-JUL-16 SL15252 (150719850) 31-JUL-16 SL15254 (150719850) 31-JUL-16 SL15254 (150820336) 31-AUG-16 SL15257 (150820336) 31-AUG-16 SL15258 (150820336) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18653]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1475-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 1148
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1475-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24677]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15174 (150518822) 31-MAY-16 SL15176 (150317997) 31-MAR-16 SV15168 (150418241) 30-APR-16 SV15168 (150117022) 31-MAR-16 SL15180 (150418241) 30-APR-16 SL15209 (150720052) 31-JUL-16 SL15210 (150720052) 31-JUL-16 SL15218 (150720052) 31-JUL-16 SL15219 (150720052) 31-JUL-16 SL15222 (150720052) 31-JUL-16 SL15246 (150820337) 31-AUG-16 SL15251 (150820337) 31-AUG-16 SL15252 (150820337) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17695]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1476-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 620
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1476-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50029]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15195-01 (150719852) 31-JUL-16 SL15195-02 (150719852) 31-JUL-16 SL15218 (150719852) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22815]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1477-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 10
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1477-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24686]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15187 (150719805) 31-JUL-16 SL15245 (150820338) 31-AUG-16 SL15264 (150920833) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17811]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1478-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 150
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1478-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32321]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15176 (150619404) 30-JUN-16 SL15199 (150719806) 31-JUL-16 SL15203 (150719806) 31-JUL-16 SL15211 (150720041) 31-JUL-16 SL15259 (150920577) 31-AUG-16 SL15260 (150920577) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[23920]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1479-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 144
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1479-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8998]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15197 (150719807) 31-JUL-16 SL15240 (150820565) 31-AUG-16 SL15240 (150820339) 31-AUG-16 SL15261 (150920708) 30-SEP-16 SL15261 (150920707) 30-SEP-16 SL15264 (150920707) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24774]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1480-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 800
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1480-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32318]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15187 (150518831) 30-JUN-16 SL15217 (150719853) 31-JUL-16 SL15233 (150820340) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18598]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1481-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 36
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1481-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50020]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15197 (150719808) 31-JUL-16 SL15240 (150820341) 31-AUG-16 SL15271 (150920991) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18672]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1482-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 125
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1482-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24683]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150619291) 30-JUN-16 SL15191-01 (150719893) 31-JUL-16 SL15223 (150820342) 31-AUG-16 SL15225 (150820343) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18694]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1483-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 1920
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1483-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20928]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15203 (150719894) 31-JUL-16 SL15208 (150518835) 31-MAY-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17799]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1484-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 108
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1484-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55987]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15169 (150619188) 30-JUN-16 SL15174 (150619405) 30-JUN-16 SL15202 (150719809) 31-JUL-16 SL15208 (150719809) 31-JUL-16 SL15210 (150720043) 31-JUL-16 SL15222 (150720043) 31-JUL-16 SL15233 (150720042) 31-JUL-16 SL15251 (150720042) 31-JUL-16 SL15260 (150920709) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19098]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1485-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 153
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1485-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24727]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15174 (150619406) 30-JUN-16 SL15197 (150719810) 31-JUL-16 SL15201-02 (150719810) 31-JUL-16 SL15231 (150820049) 31-AUG-16 SL15232 (150820049) 31-AUG-16 SL15243 (150820049) 31-AUG-16 SL15265 (150820558) 31-AUG-16 SL15268 (150920711) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19453]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1486-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 162
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1486-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44194]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15174 (150619190) 30-JUN-16 SL15181 (150619407) 30-JUN-16 SL15191-01 (150619407) 30-JUN-16 SL15197 (150719811) 31-JUL-16 SL15201-01 (150719811) 31-JUL-16 SL15254 (150820367) 30-SEP-16 SL15265 (150920712) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18500]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1487-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 800
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1487-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8991]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619315) 30-JUN-16 SL15268 (150719854) 30-SEP-16 SL15271 (150719854) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19386]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1488-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 580
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1488-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24681]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15191-01 (150719819) 31-JUL-16 SL15264 (150719819) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17701]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1489-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 16
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1489-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[14876]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15173 (150418424) 30-JUN-16 SL15175 (150619376) 30-JUN-16 SL15176 (150619376) 30-JUN-16 SL15202 (150619296) 31-JUL-16 SL15202 (150619470) 31-JUL-16 SL15203 (150719296) 31-JUL-16 SL15208 (150719812) 31-JUL-16 SL15211 (150719812) 31-JUL-16 SL15216 (150719812) 31-JUL-16 SL15266 (150920349) 30-SEP-16 SL15267 (150920350) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24874]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1490-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 238
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1490-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24679]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15175 (150619191) 30-JUN-16 SL15177 (150619191) 30-JUN-16 SL15197 (150719813) 31-JUL-16 SL15199 (150719813) 31-JUL-16 SL15222 (150820354) 31-AUG-16 SL15222 (150820353) 31-AUG-16 SL15224 (150820353) 31-AUG-16 SL15225 (150820354) 31-AUG-16 SL15261 (150920717) 30-SEP-16 SL15261 (150920716) 30-SEP-16 SL15264 (150920716) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19064]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1491-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 576
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1491-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44187]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15180 (150619377) 30-JUN-16 SL15184 (150619377) 30-JUN-16 SL15229 (150619378) 31-AUG-16 SL15230 (150819814) 31-AUG-16 SL15231 (150820356) 31-AUG-16 SL15231 (150819816) 31-AUG-16 SL15231 (150819815) 31-AUG-16 SL15259 (150920355) 30-SEP-16 SL15261 (150920357) 30-SEP-16 SL15266 (150920358) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[17774]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1492-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 8
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1492-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[55953]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOT: SL15215 (150719817) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22806]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1493-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 25
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1493-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[8990]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15170 (150518850) 30-JUN-16 SL15210 (150720045) 31-JUL-16 SL15210 (150720044) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19102]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1494-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 111
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1494-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50022]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15177 (150619484) 30-JUN-16 SL15181 (150619555) 30-JUN-16 SL15222 (150820359) 31-AUG-16 SL15271 (150920720) 30-SEP-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19401]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1495-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 30
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1495-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[24684]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15210 (150720046) 31-JUL-16 SL15210 (150719995) 31-JUL-16 SL15217 (150720047) 31-JUL-16 SL15244 (150720047) 31-JUL-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19115]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1496-2016
Initiated January 07, 2016
Classification Class II
Status Terminated
Quantity 32
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
inadequate validation/qualification of sterilization processes
Sterility assurance
reason.sterility_assurance · v1.0.0
inadequate validation/qualification of sterilization
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1496-2016
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20929]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information LOTS: SL15208 (150719996) 31-JUL-16 SL15222 (150820360) 31-AUG-16
Distribution pattern Distributed only in Puerto Rico.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[22948]
FDA event record
· Exact recall-number query on openFDA
