Reported Jun 11, 2025 · Ongoing
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Olympus EVIS EXERA III Duodenovideoscope
- Model NumberTJF-Q190V
- Lot codes and dates
- UDI-DI04953170405563
- Model NumberTJF-Q190V. All serial numbers
- Amount recalled
- 12,195 units
Where it was sold
- Nationwide
- GA
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.
This product could cause temporary or reversible health problems — stop using it.
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