Integra LifeSciences recalls AURORA Surgiscope System (models ASX15/60 and ASX15/80) due to possible obturator separation. This single-use surgical device may break during use, causing injury. Affected units include all unexpired lots.
Possibility for the obturator to break (separate).
Integra LifeSciences is recalling its AUR:URORA Surgiscope System (models ASX15/60 and ASX15/80) because the obturator part could break during use. This breakage risk might cause injury to users during surgery. The recall affects all unexpired lots of these devices.
The obturator (a thin metal rod) inside the device could break during use, potentially causing injury to the surgical team. This breakage is possible but not guaranteed to happen in every use.
Surgical teams using the AURORA Surgiscope System for procedures. The risk is highest for those performing surgeries with the device.
Check for product numbers ASX15/60 or ASX15/80 on the device packaging. The device includes a sheath, obturator, and imager. All unexpired lots are affected.
Look for product numbers ASX15/60 or ASX15/80 on the packaging to confirm if your device is affected.
The obturator (a thin metal rod) inside the device could break during use, potentially causing injury to the surgical team.
Check the product numbers on the packaging. If it's ASX15/60 or ASX15/80, it's affected. Contact Integra LifeSciences for further instructions.
The recall record does not specify when the obturator is most likely to break.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1295-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1295-2025 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.
