CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Avitene Ultrafoam Microfibrillar Collagen Hemostat recalled by Davol

Davol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat, distributed nationwide in the US. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027

Quantity recalled1,622 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1896-2026
FDA event ID: 98602
Recalling firm: Davol, Warwick, RI
Classification: Class II
Status: Ongoing
Recall initiated: 25 Mar 2026
FDA classified: 21 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

25 Mar 2026	Recall initiated by company
21 Apr 2026	Classified by FDA	+27 days
29 Apr 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Avitene Ultrafoam Microfibrillar Collagen Hemostat recalled?

Yes. Davol recalled Avitene Ultrafoam Microfibrillar Collagen Hemostat on 25 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1896-2026.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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