Cysto-Nephro Videoscope Model CYF-VHR: Reusable Brush Cleaning Instructions Updated
Olympus updated cleaning instructions for the Model CYF-VHR Cysto-Nephro Videoscope. Reusable brushes have been removed from manual cleaning procedures; 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: FDA Class II recall with no reported illnesses, injuries, or deaths. The issue is a correction to cleaning instructions rather than a hazard with demonstrated patient harm.
Plain-English summary
Olympus has issued an updated instructions document for the Model CYF-VHR Cysto-Nephro Videoscope, a medical device used in clinical settings for internal visualization procedures. The update modifies the manual cleaning procedures for the device.
Reusable cleaning brushes have been removed from the approved manual cleaning method. Single-use brushes remain fully compatible with the device and should be used for manual cleaning instead. The manufacturer has not disclosed the specific reason for this change in the source documentation.
The recall affects all serial numbers of the Model CYF-VHR Cysto-Nephro Videoscope distributed in the United States. A total of 1,547 units have been distributed in the US, and 2,772 units have been distributed outside the US.
Healthcare facilities and practitioners using this device should consult the updated instructions for use document provided by Olympus. Ensure that only single-use brushes are used for manual cleaning procedures going forward, and discontinue use of any reusable brushes for this device.
The recalled product
- Product
- Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Category
- Medical Device — Endoscopy
- Hazard
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 (2)
- UDI-DI: 04953170310522
- 04953170411298 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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