Recall events
/
Event 88499
Event summary
Timeline bucket August 05, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording C.R. Bard 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
21 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.
device · product 1 of 21
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Z-2521-2021
Recall number Z-2521-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 10,150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2521-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4899]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)
Distribution pattern US Nationwide distribution.
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[14132]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 21
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2522-2021
Recall number Z-2522-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 1760 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2522-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45241]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13806]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 21
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2523-2021
Recall number Z-2523-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 11,780 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2523-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40347]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10)
Distribution pattern US Nationwide distribution.
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[14016]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 21
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2524-2021
Recall number Z-2524-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 350 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2524-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45235]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A300318A, Lot NGEVX106, UDI (01)00801741073748(17)201228(10)
Distribution pattern US Nationwide distribution.
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[12207]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 21
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Z-2525-2021
Recall number Z-2525-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 11,600 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2525-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40344]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)
Distribution pattern US Nationwide distribution.
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[14080]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 21
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Z-2526-2021
Recall number Z-2526-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 420 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2526-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22534]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A303318A, Lot NGEVX105, UDI (01)00801741073809(17)201220(10)
Distribution pattern US Nationwide distribution.
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[13751]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 21
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Z-2527-2021
Recall number Z-2527-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 5950 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2527-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58328]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)
Distribution pattern US Nationwide distribution.
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[14006]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 21
Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
Z-2528-2021
Recall number Z-2528-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 3980 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2528-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23590]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10) Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13952]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 21
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Z-2529-2021
Recall number Z-2529-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 2660 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2529-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11457]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10)
Distribution pattern US Nationwide distribution.
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[14129]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2530-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 1140 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2530-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52054]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)
Distribution pattern US Nationwide distribution.
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[13937]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2531-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 33,380 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2531-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45238]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)
Distribution pattern US Nationwide distribution.
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[8505]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2532-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 18,060 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2532-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15603]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)
Distribution pattern US Nationwide distribution.
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[14087]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2533-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 1710 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2533-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58325]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13947]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2534-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 960 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2534-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4893]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10)
Distribution pattern US Nationwide distribution.
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[13901]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2535-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 80 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2535-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52053]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A902616, Lot NGFR3277, UDI (01)00801741104633(17)251228(10)
Distribution pattern US Nationwide distribution.
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[14011]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2536-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 29,890 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2536-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40342]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)
Distribution pattern US Nationwide distribution.
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[13950]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2537-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 40 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2537-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58323]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(10)
Distribution pattern US Nationwide distribution.
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[14084]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2538-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 8170 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2538-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[52058]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13809]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2539-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 4830 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2539-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58326]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A902416, Lot NGFR4567, UDI (01)00801741074042(17)201228(10)
Distribution pattern US Nationwide distribution.
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[14135]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2540-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 6440 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2540-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58320]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13808]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-2541-2021
Initiated August 05, 2021
Classification Class II
Status Ongoing
Quantity 1440 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
There is potential for packaging defects that may impact the sterile barrier.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging change control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2541-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40346]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall There is potential for packaging defects that may impact the sterile barrier.
Code information Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10)
Distribution pattern US Nationwide distribution.
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[13942]
FDA event record
· Exact recall-number query on openFDA
