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Model No. CYF-5R, Cystonephrofiberscope

FDA Recall #Z-0685-2024 — Class II — December 4, 2023

Recall #Z-0685-2024 Date: December 4, 2023 Classification: Class II Status: Ongoing

Product Description

Model No. CYF-5R, Cystonephrofiberscope

Reason for Recall

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Recalling Firm

Shirakawa Olympus Co., Ltd. — Nishishirakawa-Gun

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2551 US; 3738 Global

Distribution

US Nationwide distribution.

Code Information

UDI-DI: 04953170328817 04953170411182 All serial numbers

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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