Avitene Ultrafoam Microfibrillar Collagen Hemostat — Class II medical device recall Z-1896-2026
Ongoing recall by Davol, Inc., reported 2026-04-29, distributed nationwide. Potential for product to contain foreign matter, confirmed to be inspect fragments.
| Recall number | Z-1896-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Davol, Inc., Warwick, RI, United States |
| Recall initiated | 2026-03-25 |
| Classified | 2026-04-21 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, KR |
| Quantity | 1,622 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00801741010538 |
| Lot numbers | WBJS0055 |
| Model numbers | 1050030 |
| Expiration dates | 2027-07-28 |
Product
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Reason for recall
Potential for product to contain foreign matter, confirmed to be inspect fragments.
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-1896-2026. 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.