FDA Medical Device Recalls (openFDA)
Davol, Inc.: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
- Recall number
- Z-1896-2026
- Recalling firm
- Davol, Inc.
- Product
- Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
- Status
- Open, Classified
- Initiated
- 2026-03-25
- Posted
- 2026-04-21
- Terminated
- not on file
- Reason
- Potential for product to contain foreign matter, confirmed to be inspect fragments.
- Root cause
- Under Investigation by firm
- Action
- Davol, Inc. (Subsidiary of C.R. Bard, Inc.) notified consignees on about 03/25/2026 via emailed and mailed letter. Consignees were instructed to immediately discontinue use of and destroy any affected products on hand, hold in quarantine if destruction is not immediately possible, and complete and return the provided Customer Response Form. Consignees were also instructed to share the notification with anyone who needs to be aware within your organization and forwarded to any organization where affected products have been transferred. If affected product was purchased from a distributor, contact that distributor directly for further instructions and credit resolution. Distributors were instructed to immediately discontinue use of and destroy any affected products on hand, hold in quarantine if destruction is not immediately possible, and complete and return the provided Distributor Response Form. Distributors were further instructed to identify all customers within their distribution network who may have purchased any of the affected product listed in the notification and to provide a copy of the provided customer letter to all customers who may have received the affected product to advise them of this recall notification on BD s behalf. BD will issue replacement for destroyed product of the specific lot number identified above to customers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form. BD will implement appropriate corrective and preventive actions, as warranted, to reduce the risk of recurrence.
- Quantity
- 1,622 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, South Korea.
- Lot, serial or model codes
- Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMF
- Firm FEI
- 1213643
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28