FDA Device recall Z-2331-2024
AURORA Surgiscope System
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of AURORA Surgiscope System by Integra Lifesciences, citing potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2331-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-07 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Integra Lifesciences |
| Distribution | DC, NY, OH |
Product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Reason
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Identifiers
| code_info | Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Integra Lifesciences
- AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager
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FDA Device · Class II · 2025-01-29 · Integra Lifesciences - CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only
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All Integra Lifesciences recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.