AURORA Surgiscope System — Class II medical device recall Z-1295-2025
Ongoing recall by Integra LifeSciences Corp., reported 2025-03-12, distributed nationwide. Possibility for the obturator to break (separate).
| Recall number | Z-1295-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-03-06 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 623 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00850002332254 |
| Model numbers | 00850002332254, 008500023332247, ASX15/60, ASX15/80 |
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 for recall
Possibility for the obturator to break (separate).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1295-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.