Class II
Medical Device Recall: Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Cook Biotech, Inc. · November 22, 2024
Reason for Recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
States Affected
IN, MI
Quantity Affected
6 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0833-2025
Status: ongoing
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