AURORA SurgiscopeRecalls & reported problems across all models
Integra Lifesciences Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one AURORA Surgiscope model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 4 models of AURORA Surgiscope by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2024 and Jan 6, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (2 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AURORA Surgiscope recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 6, 2025Open, Classified
Possibility for the obturator to break (separate).
Z-1295-2025 · Root cause: Process control · Recall details · FDA record ↗
- Jun 7, 2024Open, Classified
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Z-2331-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported AURORA Surgiscope problems
Device problems
- Optical Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Convulsion/Seizure1
AURORA Surgiscope models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AURORA® Surgiscope® ASX15/60Retractor, Self-Retaining, For Neurosurgery1 recall1 report
- Aurora® Surgiscope® ASX9/130Endoscope, neurological1 recall0 reports
- AURORA® Surgiscope® ASX15/80Retractor, Self-Retaining, For Neurosurgery1 report
- Aurora® Surgiscope® ASX9/100RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1 report
Recent AURORA Surgiscope adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionSep 13, 2024Optical Problem; Optical Problem
MalfunctionSep 13, 2024Optical Problem; Optical Problem
Other Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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