Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile recall — FDA Z-0833-2025
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Overview of recall records associated with Cook Biotech, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 15.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
Products expire prior to the expiration date printed on the product labeling
This page summarizes recall records in which the official source identifies Cook Biotech, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.