RoyalSilk Non-Reinforced Surgical Gowns XXX-large — Class II medical device recall Z-0378-2022
Ongoing recall by Cardinal Health, reported 2021-12-22, distributed nationwide. Potential for open packaging seals compromising the sterility of the surgical gowns
| Recall number | Z-0378-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Waukegan, IL, United States |
| Recall initiated | 2021-11-02 |
| Classified | 2021-12-10 |
| Reported by FDA | 2021-12-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CO, CR, IL, MX, PA, QA, TH |
| Quantity | 8,950 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10192253006193, 50192253006191 |
| Lot numbers | 20MMQ007, 21BMQ007, 21CMQ008, 21DMQ001, 21EMQ003, 21FMQ007 |
Product
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Reason for recall
Potential for open packaging seals compromising the sterility of the surgical gowns
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-0378-2022. 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.