Avitene recallZ-1896-2026 · Davol, Inc. · initiated Mar 25, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Davol, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for product to contain foreign matter, confirmed to be inspect fragments.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1896-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2026
- Posted by the FDA
- Apr 21, 2026
- Recalling firm
- Davol, Inc.
- Quantity
- 1,622 units
- Product code
- LMF
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, South Korea.
Product description
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Code information (models, lots, serial numbers)
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Avitene 1050030Davol Inc. · Agent, absorbable hemostatic, collagen based1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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