Integra recalls SURG STRP 3/4X6 surgical strips with model 801452 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 with model number 801452 because they may contain higher-than-expected endotoxin levels. This could increase the risk of infection during surgery, especially for procedures involving the brain or central nervous system.
The surgical strips may contain higher-than-expected levels of endotoxin, a bacterial component that can cause infections. This risk is particularly concerning for surgeries involving the brain or central nervous system where infection could lead to serious complications.
Surgical professionals and patients who used the Integra SURG STRP 3/4X6 model 801452 surgical strips for brain or central nervous system procedures. Patients undergoing surgery with these strips are at the highest risk.
Check for the model number 801452 on the surgical strips. Products distributed under JnJ with the same model number also fall under this recall. All unexpired products are included.
Look for the model number 801452 on the surgical strips or the UDI-DI numbers 10381780515081 and 20886704036606.
The recall is due to identified higher-than-expected levels of endotoxin in the raw materials used to produce these surgical strips, which could lead to out-of-specification levels in finished products.
While the risk is low, higher-than-expected endotoxin levels could increase the chance of infection during surgery, especially for procedures involving the brain or central nervous system.
Check for the model number 801452 on the surgical strips or the UDI-DI numbers 10381780515081 and 20886704036606. Products distributed under JnJ with the same model number are also included.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0251-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0251-2025 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.
