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Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Recalled December 11, 2024 · FDA recall Z-0620-2025 · Olympus Corporation of the Americas
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 ). · FDA Class II
Units
1,770 units
Sold at
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Description
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 ).
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →