Integra LifeSciences recalls Extended Tip Applicator 8CM boxes due to potential endotoxin contamination and lack of sterility. Affected units may pose infection risks during medical procedures.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Integra LifeSciences is recalling Extended Tip Applicators 8CM because they may contain unsafe levels of endotoxins and not be sterile. This could lead to infections during medical procedures if used improperly.
The devices may have unsafe levels of endotoxins and lack sterility assurance. Endotoxins are bacterial components that can cause infections when introduced into the body during medical procedures.
Healthcare professionals using these applicators for medical procedures are most at risk. Patients receiving procedures with these devices could face infection risks.
Look for the Extended Tip Applicator 8CM, Box of 1 with model number 2: 201108. All lots are affected, so check the UDI 10381780000167 on the packaging.
Verify the model number 201108 and UDI 10381780000167 on the packaging to confirm if your device is affected.
The recall states the devices may contain unsafe endotoxin levels and lack sterility assurance, so they are not safe for medical use.
Look for the Extended Tip Applicator 8CM, Box of 1 with model number 201108 and UDI 10381780000167 on the packaging.
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-1960-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1960-2025 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.
