Halyard LAVH PACK — Class II medical device recall Z-2964-2026
Ongoing recall by AVID Medical, Inc., reported 2026-08-26, distributed nationwide. The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may ha
| Recall number | Z-2964-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2026-07-10 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 40 packages |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10809160372357 |
| Lot numbers | 1669869 |
| Model numbers | USAR053-11 |
| Expiration dates | 2027-04-30 |
Product
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Reason for recall
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a 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-2964-2026. 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.