Integra recalls SURG PAT XRAY 1X3 Model 801408 surgical patties and strips due to potential endotoxin levels in finished goods. This may affect surgical use during procedures involving brain or nervous system tissue.
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 1X3 Model 801408 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could pose a risk during surgery involving brain or nervous system tissue.
The recall is based on higher-than-expected endotoxin levels in the raw materials used to make the surgical products. Endotoxins are natural components of bacteria that can cause infections if they enter the body during surgery. The risk is specifically noted for procedures involving brain or nervous system tissue.
Surgical teams using these products during procedures involving brain or nervous system tissue. Patients undergoing surgery with these materials are at potential risk.
Check for the model number 801408 on the packaging. Products distributed under JnJ with the same model number may also be affected. All unexpired products are included in this recall.
Look for the model number 801408 on the packaging or product label.
The recall indicates potential endotoxin levels that could pose a risk during surgery involving brain or nervous system tissue. Integra has not provided specific instructions on whether the product is safe to use.
Integra identified higher-than-expected levels of endotoxin in the raw materials used to produce these surgical products, which may have resulted in out-of-specification levels in finished goods.
The recall specifically mentions potential risks during surgery involving brain or nervous system tissue, but does not detail specific patient risks.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0246-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0246-2025 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.
