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-Pro Endoscope Reprocessor Recalled by Olympus Corporation of the Americas Due to New warning requiring Users to conduct duodenoscope precleaning...

Date: June 23, 2016
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-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Quantity: 2, 686 units

Why Was This Recalled?

New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (50 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