FDA Device recall Z-2260-2025
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit by Avid Medical, citing CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2260-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | CA, IL, MD, OH, PA, TX, WA |
Product
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Reason
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Identifiers
| code_info | Model No. NIHB0035-07; UDI: 10809160404959; Kit Lot No. 1591938, 1622268, 1628944, 1632685. |
|---|
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-2260-2025%22
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