Reported Dec 11, 2024 · Ongoing
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
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?
- EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
- Model NumberGIF-1TH190
- Lot codes and dates
- Model NumberGIF-1TH190
- UDI
0495317034336004953170437014
- Serial Number RangeBefore 2446103 or After 2500453
- Amount recalled
- 1,770 units
Where it was sold
Why it was recalled
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
This product could cause temporary or reversible health problems — stop using it.
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