Integra recalls SURG STRP 2X6 surgical patties and strips with potential endotoxin levels exceeding safety standards. These products are used in brain and nervous system surgeries. Affected units have specific UDI numbers.
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 patties and strips (model 801455) due to possible unsafe endotoxin levels in the product. This could pose a risk during brain and nervous system surgeries if the product is used without proper testing.
The raw materials used to make these surgical products contain higher-than-expected endotoxin levels. This could lead to out-of-specification endotoxin levels in the finished products, potentially causing adverse reactions during surgery.
Surgical teams using Integra's SURG STRP 2X6 surgical patties and strips for brain or nervous system procedures. Patients undergoing these surgeries are at risk if the product is used without proper endotoxin testing.
Check for the model number 801455 on the product packaging. Products distributed under JnJ with the same UDI numbers (10381780515111 and 20886704036637) are also affected.
Look for the model number 801455 on the surgical patty or strip packaging.
The raw materials used to produce these surgical products contain higher-than-expected endotoxin levels, which may result in unsafe endotoxin levels in the finished goods.
The model number is 801455.
Yes, the UDI numbers are 10381780515111 and 20886704036637.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0254-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0254-2025 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.
