Cook Biotech, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0832-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

Product Classification:

Class II

Date Initiated: November 22, 2024

Date Posted: January 22, 2025

Recall Number: Z-0832-2025

Event ID: 95961

Reason for Recall:

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Status: Ongoing

Product Quantity: 49 devices

Code Information:

Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.

Distribution Pattern:

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated