Cook Medical recalls hiatal hernia grafts with incorrect instructions and expiration date. Affected products include specific model numbers and lot numbers. Consumers should contact for details.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Cook Medical is recalling hiatal hernia grafts that were manufactured with incorrect instructions and an outdated expiration date. This could lead to improper use or safety issues if the grafts are used without following the correct guidelines.
The recall is due to the use of an incorrect version of the instructions for use (IFU) and an incorrect expiration date on some products. This could result in improper surgical procedures or safety concerns if the grafts are used without the updated instructions.
Patients who received the Cook Medical Hiatal Hernia Graft with the specific model numbers and lot numbers listed in the recall are affected. Those who have the grafts and are undergoing surgery are most at risk.
Check for the model numbers REF C-PHR-7X10-U and REF G31455, lot number LB1579758, and expiration date 2/19/2026. The product is sterile and comes in a specific packaging with unique identifiers.
Reach out to Cook Medical directly for specific details about your product and instructions on what to do next.
The recall is due to incorrect instructions and an outdated expiration date, which could lead to improper use or safety issues if the grafts are used without following the correct guidelines.
Check for the model numbers REF C-PHR-7X10-U and REF G31455, lot number LB1579758, and expiration date 2/19/2026.
Contact Cook Medical directly for specific details about your product and instructions on what to do next.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0833-2025 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0833-2025 from Cook Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
