Class II

Medical Device Recall: Model No. CYF-5, Cystonephrofiberscope

Shirakawa Olympus Co., Ltd. · December 4, 2023

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

3457 US; 8122 Global

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0684-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Shirakawa Olympus Co., Ltd. Medical Device Recall: Model No. CYF-5, Cystonephrofiberscope | SafeCheck