Integra LifeSciences recalls 15cm Extended Tip Applicators (box of 5) due to potential endotoxin levels and lack of sterility. Affected units include all lots with model 205115.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Integra LifeSciences is recalling 15cm Extended Tip Applicators (box of : 5) because they may contain unsafe levels of endotoxins and lack proper sterility. This could pose a risk of infection or contamination for medical users.
The applicators may have unsafe levels of endotoxins and lack sterility assurance. Endotoxins are bacterial components that can cause infections if introduced into the body during medical procedures.
Medical professionals and patients using these applicators for procedures. Those with the model number 205115 are most at risk.
Check for the model number 205115 on the box. All lots of this product are affected, including those with UDI 10381780000150.
Look for model number 205115 on the box or UDI 10381780000150 to confirm affected units.
Yes, the applicators may contain unsafe levels of endotoxins and lack sterility assurance, which could lead to infections during medical procedures.
Check for model number 205115 on the box or UDI 10381780000150. All lots of this product are affected.
The recall does not specify a remedy, so contact Integra LifeSciences for guidance on next steps.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1959-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1959-2025 from Integra LifeSciences. 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.
