Integra LifeSciences recalls 8cm Extended Tip Applicators due to potential endotoxin contamination and lack of sterility. Affected units include all lots of model 205108.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Integra LifeSciences is recalling their Extended Tip Applicators (8cm, box of 5) because they may contain unsafe levels of endotoxins and not be sterile. This could pose a risk of infection or contamination if used in medical procedures.
The applicators may have unsafe levels of endotox: bacterial toxins that can cause infections. They also lack sterility assurance, meaning they might not be clean enough for medical use.
Healthcare professionals using these applicators for medical procedures are most at risk. Patients receiving treatments with these devices could also be affected.
Check for the model number 205108 on the box. All lots of this product are affected, including the UDI 10381780000143.
Look for model number 205108 on the box and UDI 10381780000143 to confirm affected units.
The recall states they may contain unsafe endotoxin levels and lack sterility, so they are not safe for medical use.
Check for model number 205108 on the box and UDI 10381780000143. All lots of this product are affected.
The recall does not specify a remedy, so contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1958-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1958-2025 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.
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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.
