Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog... recall (Davol, Inc.)
Medical deviceClass IIOngoing
Summary: Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.. Reason: Potential for product to contain foreign matter, confirmed to be inspect fragments.
What is being recalled
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Why
Potential for product to contain foreign matter, confirmed to be inspect fragments.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of China, South Korea.
How to tell if yours is affected
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1896-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | April 29, 2026 |
| Company | Davol, Inc. |
| Company location | Warwick, RI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,622 units |
More recalls from Davol, Inc. · all medical device recalls · recalls from March 2026