Recall Z-1896-2026— Davol, Inc.

Class II · Ongoing

Class II FDA medical device recall by Davol, Inc., initiated 2026-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm
Davol, Inc.
Classification
Class II
Status
Ongoing
Initiated
2026-03-25
Firm location
Warwick, RI, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.