Integra recalls SURG PAT XRAY 3X3 Model 801409 surgical patties and strips due to potential endotoxin levels exceeding specifications, which could pose risks 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 SURG PAT XRAY 3X3 Model 801409 surgical patties and strips because they may contain higher-than-expected endotoxin levels. This could affect surgical safety during procedures involving brain or nervous system tissue.
The raw materials 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 affecting surgical safety during procedures involving brain or nervous system tissue.
Surgical teams using the SURG PAT XRAY 3X3 Model 801409 surgical patties and strips for brain or nervous system procedures. Patients undergoing surgery with these products are at potential risk.
Check for the model number 801409 on the product packaging. The product was distributed under both Integra and JnJ brand names with two unique UDI numbers: 10381780515043 and 20886704036569.
Look for the model number 801409 on the packaging or product label.
The recall is due to identified higher-than-expected levels of endotoxin in the raw materials, which may result in out-of-specification endotoxin levels in finished products.
The recall indicates potential risks, so users should check if they have the recalled model and follow the action steps.
The product was distributed under both Integra LifeSciences Corp. and Johnson & Johnson brand names with two unique UDI numbers.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0247-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0247-2025 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.
