Integra recalls SURG PAT XRAY 1/4X1/4 Model 801399 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may pose risks during surgery.
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
Integra is recalling SURG PAT XRAY 1/4X1/4 Model 801399 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could affect surgical procedures involving brain or central nervous system tissue protection.
The raw material used to make these surgical products may have contained higher-than-expected endotoxin levels. This could lead to out-of-specification levels in the finished products, potentially affecting surgical outcomes.
Surgical teams using these products for brain or central nervous system procedures during surgery. Patients undergoing such surgeries are at potential risk if the products are used.
Check for the model number 801399 on the product packaging. Products were sold with UDI numbers 10381780514954 and 20886704036477. The same product was distributed under JnJ for a few years under a transition agreement.
Look for the model number 801399 and UDI numbers 10381780514954 or 20886704036477 on the packaging.
The recall states there may be higher-than-expected endotoxin levels, but the product is still intended for use in surgery. Affected products should be checked and handled with caution.
Integra identified higher-than-expected endotoxin levels in the raw material used to produce these surgical products, which could lead to out-of-specification levels in finished goods.
Surgical teams using these products for brain or central nervous system procedures during surgery, as the products are intended for tissue protection in such contexts.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0238-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0238-2025 from Integra. 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.
