CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Model No. Cyf-5, Cystonephrofiberscope recalled by Shirakawa Olympus Co
Shirakawa Olympus is recalling Model No. Cyf-5, Cystonephrofiberscope, distributed nationwide in the US. The recall was initiated on 4 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0684-2024
- FDA event ID
- 93583
- Recalling firm
- Shirakawa Olympus, Nishishirakawa-Gun
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2023
- FDA classified
- 9 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Dec 2023 | Recall initiated by company | |
| 9 Jan 2024 | Classified by FDA | +36 days |
| 17 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Product as listed by the FDA
Model No. CYF-5, Cystonephrofiberscope
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Which lots are affected?
UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 93583This product is part of a recall event; the main page for the event is Model No. Cyf-V2, Visera Cysto-Nephro Videoscope recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Model No. Cyf-V2, Visera Cysto-Nephro Videoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. Cyf-vh, Cysto-nephro Videoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. Cyf-vhr, Cysto-nephro Videoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. BF-XP190, Evis Exera III Bronchovideoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. Cyf-V2R, Visera Cysto-Nephro Videoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. Cyf-5R, Cystonephrofiberscope recalled by Shirakawa Olympus Co | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. BF-P190, Evis Exera III Bronchovideoscope recalled | Shirakawa Olympus | Other | Nationwide | |
| CLASS II | Model No. Enf-xp, Rhino-laryngofiberscope recalled | Shirakawa Olympus | Other | Nationwide |
More recalls from Shirakawa Olympus
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Model No. Enf-xp, Rhino-laryngofiberscope recalled | Shirakawa Olympus | Other | Nationwide |
| Device | CLASS II | Model No. BF-P190, Evis Exera III Bronchovideoscope recalled | Shirakawa Olympus | Other | Nationwide |
| Device | CLASS II | Model No. Cyf-5R, Cystonephrofiberscope recalled by Shirakawa Olympus Co | Shirakawa Olympus | Other | Nationwide |
| Device | CLASS II | Model No. Cyf-V2R, Visera Cysto-Nephro Videoscope recalled | Shirakawa Olympus | Other | Nationwide |
| Device | CLASS II | Model No. BF-XP190, Evis Exera III Bronchovideoscope recalled | Shirakawa Olympus | Other | Nationwide |
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