Recall events
/
Event 89015
Event summary
Timeline bucket November 02, 2021
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Cardinal Health
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
11 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 11
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Z-0368-2022
Recall number Z-0368-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 224,312 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0368-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51993]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7440]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 11
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Z-0369-2022
Recall number Z-0369-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 169,262 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0369-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16531]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7384]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 11
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Z-0370-2022
Recall number Z-0370-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 231,219 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0370-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58540]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7487]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 11
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Z-0371-2022
Recall number Z-0371-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 363,480 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0371-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4450]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7423]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 11
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Z-0372-2022
Recall number Z-0372-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 17,174 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0372-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34700]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7518]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 11
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Z-0373-2022
Recall number Z-0373-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 146,939 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0373-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26781]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MEQ001 21AEQ00 21BEQ001 21BEQ002 21BEQ003 21CEQ001 21DEQ001 21DEQ002 21EEQ001 21EEQ002 21FEQ001 21FEQ002 21GEQ001 21HEQ001 21HEQ002 21JEQ001 21JEQ002. UDI: 50192253018989 (cs) 10192253018981 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7280]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 11
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Z-0374-2022
Recall number Z-0374-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 29,893 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0374-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22037]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 21CKQ001 21CKQ002 21HKQ001. UDI: 50192253005941 (cs) 10192253005943 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7433]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 11
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Z-0375-2022
Recall number Z-0375-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 364,481 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0375-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45275]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7619]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 11
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Z-0376-2022
Recall number Z-0376-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 270,839 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0376-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58541]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7377]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0377-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 9,990 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0377-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22038]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7342]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0378-2022
Initiated November 02, 2021
Classification Class II
Status Ongoing
Quantity 8,950 units
App-derived interpretation
Labeling or packaging
reason.labeling_packaging · v1.0.0
open packaging
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0378-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45273]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for open packaging seals compromising the sterility of the surgical gowns
Code information Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)
Distribution pattern Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
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[7447]
FDA event record
· Exact recall-number query on openFDA
