FDA recall Z-1896-2026

Davol, Inc. · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of China, South Korea.

Key facts

Status
Ongoing
Initiation date
2026-03-25
Report date
2026-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warwick, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1896-2026