Class II — Potential Health Hazard

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

CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Recalled by Aizu Olympus Co., Ltd. Due to Specific devices may have an improperly repaired light...

Date: October 16, 2023
Company: Aizu 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 Aizu Olympus Co., Ltd. directly.

Affected Products

CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE

Quantity: 24 incorrectly repaired units

Why Was This Recalled?

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Where Was This Sold?

This product was distributed to 6 states: FL, KY, MA, NJ, NY, PA

Affected (6 states)Not affected

About Aizu Olympus Co., Ltd.

Aizu Olympus Co., Ltd. has 31 total recalls tracked by RecallDetector.

Related Recalls

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