CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
Aurora Surgiscope System, Sterile recalled by Integra LifeSciences
Integra LifeSciences is recalling Aurora Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, distributed nationwide in the US. The recall was initiated on 6 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1295-2025
- FDA event ID
- 96216
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2025
- FDA classified
- 6 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Feb 2025 | Recall initiated by company | |
| 6 Mar 2025 | Classified by FDA | +28 days |
| 12 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possibility for the obturator to break (separate).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Where it was distributed
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.
Nationwide CaliforniaDistrict of ColumbiaFloridaIllinoisKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Possibility for the obturator to break (separate).
Which lots are affected?
Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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