Integra recalls SURG PAT XRAY 1X1 Model 801403 surgical patties and strips due to potential endotoxin levels exceeding specifications, which could 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 1X1 Model 801403 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could theoretically affect surgical safety, though the risk is not confirmed to cause actual harm.
The recall is based on higher-than-expected endotoxin levels in the raw materials used to make the surgical products. Endotoxins are bacterial components that can cause inflammation or infection if they enter the body during surgery. However, the risk is not confirmed to cause actual harm in normal use.
Surgical teams and hospitals that use Integra's SURG PAT XRAY 1X1 Model 801403 surgical patties and strips for brain and nervous system procedures. Patients undergoing surgery with these products may be at slightly higher risk due to potential endotoxin levels.
Check for the model number 801403 on the product packaging. Products distributed under JnJ (Johnson & Johnson) with the same model number are also included in this recall. All unexpired products are affected.
Look for the model number 801403 on the surgical patty or strip packaging.
The recall is based on potential higher endotoxin levels, but the risk is not confirmed to cause actual harm. Integra has not stated that the product is unsafe for use.
Integra identified higher-than-expected endotoxin levels in the raw materials used to produce these surgical products, which could lead to out-of-specification levels in finished goods.
No, the recall does not require stopping use. The product is still considered safe for use, but the manufacturer is monitoring the situation.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0242-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0242-2025 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.
