Integra AURORA Surgiscope System Recall: Risk of Obturator Breaking
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.
Lower-risk recall
Possibility for the obturator to break (separate).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/52936-integra-aurora-surgiscope-system-recall-risk-of-obturator-breaking.
Source Summary by GovInfoNow · govinfonow.com/recall/52936-integra-aurora-surgiscope-system-recall-risk-of-obturator-breaking · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1295-2025
Cite this page
“Integra AURORA Surgiscope System Recall: Risk of Obturator Breaking.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52936-integra-aurora-surgiscope-system-recall-risk-of-obturator-breaking. Based on FDA recall #Z-1295-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Surgical teams using the AURORA Surgiscope System for procedures. The risk is highest for those performing surgeries with the device.
How to tell if you have this one
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.
- Brand
Integra LifeSciences- Category
Medical device
What to do — step by step
Check Device Packaging
Look for product numbers ASX15/60 or ASX15/80 on the packaging to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
FDA distribution: “US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1295-2025 (February 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1295-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.