FDA Device recall Z-0375-2022
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 by Cardinal Health, citing potential for open packaging seals compromising the sterility of the surgical gowns.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0375-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-02 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Reason
Potential for open packaging seals compromising the sterility of the surgical gowns
Identifiers
| code_info | Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ00…Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0375-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.