Recall Z-1896-2026 ยท LMF Agent, Absorbable Hemostatic, Collagen Based
Davol, Inc.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
| Date | Apr 21, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | Potential for product to contain foreign matter, confirmed to be inspect fragments. |
| Root cause | Under Investigation by firm |
| Action | Davol, Inc. (Subsidiary of C.R. Bard, Inc.) notified consignees on about 03/25/2026 via emailed and mailed letter. Consignees were instructed to immediately discontinue use of and destroy any affected products on hand, hold in quarantine if destruction is not immediately possible, and complete and return the provided Customer Response Form. Consignees were also instructed to share the notification with anyone who needs to be aware within your organization and forwarded to any organization where affected products have been transferred. If affected product was purchased from a distributor, conta |
| Quantity | 1,622 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of China, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.