Olympus Corporation of the Americas recalls Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

Recall date

May 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1911-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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