Integra recalls SURG STRP 1X6-200 surgical strips due to potential endotoxin levels in finished products that could cause infection 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 surgical strips and patties with model number 801453 because they may contain higher-than-expected endotoxin levels. This could increase infection risk during surgery, especially for brain and nervous system procedures.
The surgical strips may contain higher-than-expected endotoxin levels from the raw materials used. Endotoxins are bacterial components that can cause infections if introduced into the body during surgery.
Surgical teams using these strips for brain or nervous system procedures. Patients undergoing surgery with these products are at potential risk of infection.
Check for model number 801453 on the packaging. These products were sold under Integra and JnJ with two unique UDI numbers: 10381780515098 and 20886704036613. All unexpired products are included in this recall.
Look for model number 801453 on the packaging or label of the surgical strips.
The recall is due to identified higher-than-expected endotoxin levels in the raw materials used to produce these surgical strips, which could lead to infection during surgery.
The potential risk is infection during surgery, particularly for brain and nervous system procedures, but the recall is for products that may have out-of-specification endotoxin levels.
Check for model number 801453 and UDI numbers 10381780515098 or 20886704036613 on the packaging.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0252-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0252-2025 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.
