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

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

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.