Cystonephrofiberscope Model CYF-5R Cleaning Procedure Recall: Reusable Brushes Removed
Shirakawa Olympus Co., Ltd. is updating cleaning instructions for the Model CYF-5R Cystonephrofiberscope. Reusable cleaning brushes have been removed from manual cleaning procedures; single-use brushes remain approved.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with a precautionary instruction update regarding cleaning procedures. No reported illnesses, injuries, or deaths are mentioned in the source.
Plain-English summary
The Model CYF-5R Cystonephrofiberscope, manufactured by Shirakawa Olympus Co., Ltd., is the subject of an FDA Class II recall. The device received US Nationwide distribution, with 2,551 units distributed in the United States and 3,738 units distributed globally.
Olympus has updated the instructions for use regarding manual cleaning procedures. Reusable cleaning brushes have been removed from the approved manual cleaning protocol. Single-use cleaning brushes remain compatible with the device. The updated instructions apply to all serial numbers of this model.
The recalled product
- Product
- Model No. CYF-5R, Cystonephrofiberscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- Hazard
- cross-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170328817 04953170411182 All serial numbers
Distribution
Distributed nationwide across the United States.
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