Integra recalls SURG PAT XRAY 1/2X2 Model 801406 surgical patties and strips due to potential endotoxin levels in finished goods. Affected products may 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 1/2X2 Model 801406 surgical patties and strips because higher-than-expected endotoxin levels in the raw materials could lead to out-of-specification endotoxin levels in the final products. This could potentially affect surgical procedures involving brain and nervous system tissue.
The raw materials used to make these surgical products contained higher-than-expected endotoxin levels. This could result in finished products having endotoxin levels outside acceptable specifications, potentially affecting surgical outcomes.
Surgical teams and hospitals using Integra's SURG PAT XRAY 1/2X2 Model 801406 surgical patties and strips for brain and nervous system procedures. Patients undergoing surgery with these products may be at risk.
Check for the model/catalno 801406 on the product packaging. Products distributed under JnJ with the same model number are also affected. All unexpired products are included in this recall.
Look for the model/catalno 801406 on the product packaging or check the UDI-DI numbers 10381780515012 and 20886704036538.
The raw materials used to produce these surgical products contained higher-than-expected endotoxin levels, which could result in finished products having endotoxin levels outside acceptable specifications.
Yes, products distributed under JnJ with the same model number 801406 are included in this recall due to a transition agreement.
The recall record does not specify a remedy, so check with Integra or your healthcare provider for guidance.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-0244-2025 — Integra Integra Hello, I own a Integra that is covered by recall Z-0244-2025 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.
