Class II — Potential Health Hazard

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

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of Recalled by Olympus Corporation of the Americas Due to The detergent and alcohol tank tubing may have...

Date: December 13, 2021
Company: Olympus Corporation of the Americas
Status: Terminated
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 Olympus Corporation of the Americas directly.

Affected Products

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Quantity: 295 units

Why Was This Recalled?

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

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