Halyard TRANSPORT BAG KIT — Class II medical device recall Z-1338-2026
Ongoing recall by AVID Medical, Inc., reported 2026-02-18, distributed nationwide. Tyvek bag seal issue which may compromise sterility of the kit.
| Recall number | Z-1338-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2026-01-02 |
| Classified | 2026-02-09 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,500 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10809160314500 |
| Lot numbers | 1650056 |
| Expiration dates | 2028-07-24 |
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Reason for recall
Tyvek bag seal issue which may compromise sterility of the kit.
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-1338-2026. 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.