Warning
Davol Recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1896-2026Medical Device
Davol Recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x
Davol, Inc. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Davol, Inc. has recalled a medical device that the FDA classified as Class II affecting 1,622 units. The recall was initiated on March 25, 2026. Potential for product to contain foreign matter, confirmed to be inspect fragments. It was distributed internationally, including the United States. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.