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U.S. Department of Health and Human Services

Class 2 Device Recall Avitene Ultrafoam Microfibrillar Collagen Hemostat

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 Class 2 Device Recall Avitene Ultrafoam Microfibrillar Collagen Hemostatsee related information
Date Initiated by FirmMarch 25, 2026
Date PostedApril 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1896-2026
Recall Event ID 98602
Product Classification Agent, absorbable hemostatic, collagen based - Product Code LMF
ProductAvitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Code Information Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
FEI Number 1213643
Recalling Firm/
Manufacturer		 Davol, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information ContactKevin Smith
401-8258328
Manufacturer Reason
for Recall		Potential for product to contain foreign matter, confirmed to be inspect fragments.
FDA Determined
Cause 2		Under Investigation by firm
ActionDavol, 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 in Commerce1,622 units
DistributionWorldwide distribution - US Nationwide and the countries of China, South Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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