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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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