FDA recall, , Moderate risk
Davol Avitene Ultrafoam Microfibrillar Collagen Hemostat
Avitene Ultrafoam Microfibrillar Collagen Hemostat may contain foreign matter, confirmed to be inspect fragments.
Summary by Recall Canary from the FDA notice
What happened
Davol, Inc., of Warwick, Rhode Island, recalled Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm because the product may contain foreign matter, confirmed to be inspect fragments. The recall began March 25, 2026, and was added to the FDA's Enforcement Report on April 21, 2026.
The product was distributed worldwide, including US Nationwide and the countries of China and South Korea.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and catalog code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm.
- UDI-DI
- 00801741010538
- Catalog code
- 1050030.
- Lot code
- WBJS0055
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of China, South Korea.
- Company
- Davol, Inc.Warwick, Rhode Island
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98602
- Recall number
- Z-1896-2026
- Quantity recalled
- 1,622 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
