Integra recalls Codman Surgical Patties and Strips (model 801396) due to potential endotoxin levels exceeding specifications in finished products. Affected items may pose a risk 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 Codman Surgical Patt:ies and Strips (model 801396) because raw materials used in production had higher-than-expected endotoxin levels, which could lead to out-of-specification endotoxin levels in the final products. This recall affects surgical use where endotoxin levels might impact patient safety during procedures.
Endotoxins are natural components of bacterial cell walls that can cause inflammation and infection when introduced into the body. Higher-than-expected levels in the surgical products could lead to adverse reactions during surgery, particularly in sensitive tissues like the brain.
Surgical teams and hospitals that use Codman Surgical Patties or Strips (model 801396) are affected. Patients undergoing surgery with these products may be at risk if endotoxin levels are not within safe limits.
Check for the model number 801396 on the product packaging. Products distributed under JnJ with the same model number are also affected. The lot codes UDI# 10381780514923 and 20886704036446 are listed for affected items.
Look for the model number 801396 on the packaging or label of the Codman Surgical Patties or Strips.
The recall is due to higher-than-expected endotoxin levels in the raw materials used to produce the products, which could result in out-of-specification endotoxin levels in the finished goods.
Yes, affected products have lot codes UDI# 10381780514923 and 20886704036446.
The recall indicates a potential risk, but the products are still safe to use if they have not been exposed to the endotoxin levels that could cause harm. Affected items should be checked and handled according to the recall instructions.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0235-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0235-2025 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.
