Cook Biotech, Inc. 2025-01-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0833-2025
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and Recall
Issued January 22, 2025 · Cook Biotech, Inc.
In January 2025, Cook Biotech, Inc. recalled the Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
What you should do
- 1 Stop using Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cook Biotech, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cook Biotech, Inc.
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Recall number
- FDA-Z-0833-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Cook Biotech, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.