FDA Device recall Z-2263-2025
ROBOTIC URO/GYN PACK. Medical convenience kit
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of ROBOTIC URO/GYN PACK. 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-2263-2025 |
| 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
ROBOTIC URO/GYN PACK. Medical convenience kit.
Reason
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Identifiers
| code_info | Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997. |
|---|
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-2263-2025%22
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