Lab Coats SMS Large White — Class II medical device recall Z-1093-2021
Ongoing recall by Cardinal Health 200, LLC, reported 2021-02-17, distributed nationwide. There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debri
| Recall number | Z-1093-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2021-01-07 |
| Classified | 2021-02-05 |
| Reported by FDA | 2021-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CH, CL, IL, JP, NL, SA, SG, ZA |
| Quantity | 29,810,665 total |
| Reason classes | foreign material |
Product
Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.
Reason for recall
There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1093-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.