FDAFDA · Food and drugs·Recall number Z-0686-2024
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Published January 17, 2024 · Recall initiated: December 4, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 04953170342110 All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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