Class II — Potential Health Hazard

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

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V Recalled by Olympus Corporation of the Americas Due to Recent post-market surveillance data suggests a possible association...

Date: May 5, 2025
Company: Olympus Corporation of the Americas
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 Olympus Corporation of the Americas directly.

Affected Products

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

Quantity: 12,195 units

Why Was This Recalled?

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

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