Cook Biotech, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0833-2025)

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 Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Product Classification:

Class II

Date Initiated: November 22, 2024

Date Posted: January 22, 2025

Recall Number: Z-0833-2025

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: 6 devices

Code Information:

Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.

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