Halyard SUTURE PACK CABG — Class II medical device recall Z-1742-2025
Ongoing recall by AVID Medical, Inc., reported 2025-05-21, distributed nationwide. An issue with a raw material used to coat some surgical needles that may result in diminished performance and/
| Recall number | Z-1742-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2025-03-31 |
| Classified | 2025-05-09 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 60 units |
| UPC / GTIN / UDI-DI | 10809160450680 |
| Lot numbers | 1642454 |
| Model numbers | SILV800-01 |
| Expiration dates | 2028-02-04 |
Product
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Reason for recall
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
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-1742-2025. 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.