FDAOctober 31, 2024device

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

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

The hazard

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 ).

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0495317034336004953170437014

Recall history

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

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