Reported Jan 22, 2025 · Ongoing
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Cook Biotech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Biotech, Inc. · 1425 Innovation Pl · W Lafayette, IN · 47906-1000
Is this the product you have?
- Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
- Lot codes and dates
Lot #LB1579758exp. 2/19/2026Box UDI-DI 10827002314556Pouch UDI-DI 00827002314559
- Amount recalled
- 6 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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