Aero Blue Performance Surgical Gown — Class II medical device recall Z-0343-2023
Ongoing recall by Owens & Minor Distribution, Inc., reported 2022-12-07, distributed in IL, IN, WV. Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery co
| Recall number | Z-0343-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owens & Minor Distribution, Inc., Mechanicsville, VA, United States |
| Recall initiated | 2022-10-31 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Distributed | IL, IN, WV |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10680651417340 |
| Lot numbers | AH1215T51 |
Product
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Reason for recall
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
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-0343-2023. 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.