Davol, Inc.: Agent, Absorbable Hemostatic, Collagen Based

Recalling firm
Davol, Inc.
Product
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.
Classification
Class III
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-25
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/282ae484-8bc1-4fca-ac4f-8c17b216787c