Model CYF-5 cystonephrofiberscope cleaning instructions updated by Olympus
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.
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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is a precautionary instruction update addressing cleaning procedures to prevent potential device contamination.
Plain-English summary
Shirakawa Olympus Co., Ltd. has issued updated instructions for use for the Model CYF-5 cystonephrofiberscope medical device. The updated instructions remove reusable cleaning brushes from the approved manual cleaning procedures. Single-use brushes remain fully compatible with the device.
This instruction update applies to all Model CYF-5 units. Healthcare providers and facility staff should obtain and review the updated instructions immediately.
Facilities should discontinue manual cleaning procedures using reusable brushes and switch to single-use brushes only. Contact Shirakawa Olympus Co., Ltd. for updated instructions or with questions about proper cleaning procedures for the Model CYF-5 cystonephrofiberscope.
The recalled product
- Product
- Model No. CYF-5, Cystonephrofiberscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
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: 04953170292323 04953170339417 04953170411144 All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Shirakawa Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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