Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Summary
The FDA issued a Class II for Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog by Davol, Inc.. Reason: Potential for product to contain foreign matter, confirmed to be inspect fragments..
Details
Source
Device Recall
External ID
Z-1896-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Lot/Code Info: Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Quantity Affected: 1,622 units
Reason for Recall
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Warwick, RI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Davol, Inc. has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Davol, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Davol, Inc. have FDA actions?
Davol, Inc. has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1896-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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