Orthopedic Pack — Class II medical device recall Z-2520-2025
Ongoing recall by O&M HALYARD INC, reported 2025-09-10, distributed nationwide. Surgical drape packs may have open seals, which may compromise the sterility of the product.
| Recall number | Z-2520-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | O&M HALYARD INC, Alpharetta, GA, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 1,316 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 30680651771651, 30680651880414 |
| Model numbers | 77165-06, 88041-12, AC2424601B, AC2424902B |
Product
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Reason for recall
Surgical drape packs may have open seals, which may compromise the sterility of the product.
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-2520-2025. 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.