Integra recalls SURG PAT XRAY 1/4X1-1/2 Model 801397 surgical patties and strips due to potential endotoxin levels in finished goods that could affect surgical safety.
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 1/4X1-1/2 Model 801397 surgical patties and strips because raw materials may have contained higher-than-expected endotoxin levels. This could lead to out-of-specification endotoxin levels in the final products, potentially affecting surgical safety during procedures.
The raw materials used to make these surgical patties and strips contained higher-than-expected endotoxin levels. This could result in finished products having endotoxin levels outside the acceptable range, which might affect surgical safety during procedures.
Surgical professionals using these products for brain and central nervous system procedures. Patients undergoing surgery with these items may be at risk if endotoxin levels are not within safe limits.
Check for the model number 801397 on the product. Products were sold with lot codes UDI# 10381780514930 and 20886704036453. The product was distributed under both Integra and JnJ brand names during a transition period.
Look for model number 801397 and lot codes UDI# 10381780514930 or 20886704036453 on the product packaging.
The raw materials used to produce these surgical patties and strips contained higher-than-expected endotoxin levels, which could result in finished products having out-of-specification endotoxin levels.
The recall is due to potential endotoxin levels in finished goods that could affect surgical safety, but the product is not unsafe if used properly with the correct endotoxin levels.
The product was distributed under both Integra and JnJ brand names during a transition period, with the same model number 801397.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0236-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0236-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
