FDA Device recall Z-0684-2024
Model No. CYF-5, Cystonephrofiberscope
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Model No. CYF-5, Cystonephrofiberscope by Shirakawa Olympus, citing olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0684-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-04 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Shirakawa Olympus |
| Distribution | US |
Product
Model No. CYF-5, Cystonephrofiberscope
Reason
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Identifiers
| code_info | UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers |
|---|
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-0684-2024%22
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