Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Model No. CYF-5R Recalled by Shirakawa Olympus Co., Ltd. Due to Olympus has updated the instructions for use: Reusable...

Date: December 4, 2023
Company: Shirakawa Olympus Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shirakawa Olympus Co., Ltd. directly.

Affected Products

Model No. CYF-5R, Cystonephrofiberscope

Quantity: 2551 US; 3738 Global

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Shirakawa Olympus Co., Ltd.

Shirakawa Olympus Co., Ltd. has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report