FDA recall Z-0691-2024

Product

Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

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.

Key facts

Status

Ongoing

Initiation date

2023-12-04

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nishishirakawa-Gun, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0691-2024