FDA DevicesClass II
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog...
Published: April 29, 2026Recall ID: Z-1896-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Product Description & Identification
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Additional Source Details
| Field | Value |
|---|---|
| City | Warwick |
| State | RI |
| Event id | 98602 |
| Address 1 | 100 Crossings Blvd |
| Address 2 | N/A |
| Code info | Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027 |
| Postal code | 02886-2850 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 1,622 units |
| Reason for recall | Potential for product to contain foreign matter, confirmed to be inspect fragments. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260421 |
Overview
- Recalling FirmDavol, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of China, South Korea.