← FDA ENFORCEMENT
Z-1896-2026Class II

Davol, Inc.

Recalling firm
Davol, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Firm state
RI
Product quantity
1,622 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Potential for product to contain foreign matter, confirmed to be inspect fragments.

Product description

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

Code / lot info

Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.