FDA Device recall Z-1295-2025
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager by Integra Lifesciences, citing possibility for the obturator to break (separate).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1295-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-06 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
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
Reason
Possibility for the obturator to break (separate).
Identifiers
| code_info | Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2025%22
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