Nishishirakawa-Gun, Japan
Shirakawa Olympus Co., Ltd. recalls
1 recall recorded since 2018, most recently on 4 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 December 2023
- Reason
- Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0691-2024, Z-0689-2024, Z-0690-2024, Z-0687-2024, Z-0692-2024, Z-0685-2024, Z-0686-2024, Z-0684-2024, Z-0688-2024
- Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
- Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
- Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
- Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
- Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
- Model No. CYF-5R, Cystonephrofiberscope
- Model No. BF-P190, EVIS EXERA III Bronchovideoscope
- Model No. CYF-5, Cystonephrofiberscope
- and 1 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.