The Recall Desk
ModerateFDA (Devices)·Z-0690-2024·Announced 2024-01-17

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.
Hazard
  • device-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 (2)

  • UDI-DI: 04953170310522
  • 04953170411298 All serial numbers

Distribution

Distributed nationwide across the United States.