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

FDA device recall Z-1896-2026 · posted 2026-04-21 · Open, Classified

Recall details

Recalling firm

Davol, Inc.

Reason for recall

Potential for product to contain foreign matter, confirmed to be inspect fragments.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LMF

Quantity affected

1,622 units

Distribution

Worldwide distribution - US Nationwide and the countries of China, South Korea.

Date initiated

2026-03-25

Date posted

2026-04-21

Location

Warwick, RI