Integra recalls SURG PAT XRAY 3/4X3/4 Model 801401 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may have out-of-specification endotoxin levels.
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 3/4X3/4 Model 801401 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could pose a risk during surgery, though the recall does not specify if the endotoxin levels caused actual harm.
The raw material used to make these surgical products may have contained higher-than-expected endotoxin levels. This could lead to out-of-specification endotoxin levels in the finished products, potentially causing complications during surgery.
Surgical professionals and hospitals using Integra's SURG PAT XRAY 3/4X3/4 Model 801401 surgical patties and strips for brain and central nervous system procedures. Patients undergoing surgery with these products may be at risk.
Check for the model/catalno 801401 on the product packaging. Products were sold with lot codes UDI# 10381780514978 and 20886704036491. The same product was distributed under JnJ for a few years under a transition agreement.
Look for the model number 801401 and lot codes UDI# 10381780514978 or 20886704036491 on the packaging.
The recall indicates potential endotoxin levels in finished goods, but the official notice does not specify if the endotoxin levels caused actual harm or injuries.
Integra LifeSciences Corp. distributed this product, and for a few years under a transition agreement with JnJ.
The recall states higher-than-expected endotoxin levels in raw materials could lead to out-of-specification endotoxin levels in finished goods, but the official notice does not specify if this caused actual harm or injuries.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0240-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0240-2025 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.
