Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cook Medical Biodesign Hiatal Hernia Graft Recalled by Cook Biotech, Inc. Due to Incorrect version of IFU was used rather than...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Biotech, Inc. directly.
Affected Products
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Quantity: 6 devices
Why Was This Recalled?
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Where Was This Sold?
This product was distributed to 2 states: IN, MI
About Cook Biotech, Inc.
Cook Biotech, Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report