Medical device recalls Moderate risk

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6 recalled over foreign material

Recall date
March 25, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Davol, Inc. recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Recall number
Z-1896-2026
FDA classification
Class II
Brand / firm
Davol, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of China, South Korea.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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