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FDAMay 5, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170405563

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V — Recall Details · AllClear