AURORA Surgiscope System — Class II medical device recall Z-2331-2024
Ongoing recall by Integra LifeSciences Corp., reported 2024-07-17, distributed in DC, NY, OH. Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
| Recall number | Z-2331-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-06-07 |
| Classified | 2024-07-10 |
| Reported by FDA | 2024-07-17 |
| Distributed | DC, NY, OH |
| Quantity | 14 units |
| UPC / GTIN / UDI-DI | 00850002332278 |
| Lot numbers | 7336314 |
| Model numbers | ASX9/130 |
Product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Reason for recall
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
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-2331-2024. 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.