FDA Enforcement
Class II
Ongoing
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Recall: Z-1896-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1896-2026
- Event ID
- 98602
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Davol, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 29, 2026
- Initiation Date
- March 25, 2026
- Classification Date
- April 21, 2026
- Address
- 100 Crossings Blvd, N/A, Warwick, RI, 02886-2850, United States
Description
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Reason
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Code Info
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Quantity
1,622 units