Shirakawa Olympus Co., Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0684-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Model No. CYF-5, Cystonephrofiberscope

Product Classification:

Class II

Date Initiated: December 4, 2023

Date Posted: January 17, 2024

Recall Number: Z-0684-2024

Event ID: 93583

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.

Status: Ongoing

Product Quantity: 3457 US; 8122 Global

Code Information:

UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated