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 - x, 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
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.
Questions about this recall
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 26 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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