Z-1896-2026Class II

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030

Name: Z-1896-2026 Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030
Creator: Davol, Inc.
Published: 2026-03-25
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2026-03-25 / Open, Classified

FDA source

Davol, Inc. began a recall of Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030 on 2026-03-25. FDA classified it as Class II and gives the reason as "Potential for product to contain foreign matter, confirmed to be inspect fragments". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1896-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-04-21
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
Reason for recall: Potential for product to contain foreign matter, confirmed to be inspect fragments.
FDA 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 in commerce: 1,622 units
Distribution: Worldwide distribution - US Nationwide and the countries of China, South Korea.
Product codes and lots: Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1896-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1896-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-21

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)