Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog… — Class II medical device recall Z-0983-2025
Ongoing recall by O&M HALYARD, INC., reported 2025-01-29, distributed nationwide. Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
| Recall number | Z-0983-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | O&M HALYARD, INC., Mechanicsville, VA, United States |
| Recall initiated | 2024-11-26 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,440 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 30680651882319 |
| Lot numbers | AC2335502D |
| Model numbers | 88231 |
Product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Reason for recall
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
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-0983-2025. 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.