Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Recall date

October 31, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0620-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

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.

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 ).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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