Integra recalls SURG PAT XRAY 1/2X3 Model 801407 surgical patties and strips due to potential endotoxin levels exceeding safety standards. These products are used in brain and nervous system surgeries. Unexpired products may be affected.
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 1/2X3 Model 801407 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could pose a risk during surgery, especially for brain and nervous system procedures.
The raw material used to make these surgical products contained higher-than-expected endotoxin levels. This could lead to out-of-specification endotoxin levels in the finished products, which might cause complications during surgery.
Surgical teams using these products during procedures involving brain or nervous system tissue. Patients undergoing surgery with these specific surgical items are at potential risk.
Check for the model number 801407 on the product 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 801407 on the surgical patty or strip packaging.
The recall states these products may contain higher-than-expected endotoxin levels, but the exact risk level is not specified. Integra has not provided a clear remedy for safe use.
Integra identified higher-than-expected endotoxin levels in the raw material used to produce these surgical products, which could result in out-of-specification endotoxin levels in finished goods.
The recall record does not specify any remedy or action steps. You should check the product details to see if it matches the model number 801407.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0245-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0245-2025 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.
