Medical device recalls Moderate risk

Shirakawa Olympus Co., Ltd. recalls Model No. CYF-5R, Cystonephrofiberscope

Recall date
December 4, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0685-2024
FDA classification
Class II
Brand / firm
Shirakawa Olympus Co., Ltd.
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Model No. CYF-5R, Cystonephrofiberscope

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