Olympus Corporation of the Americas: Device Recall

Recall #Z-0620-2025 · 10/31/2024

Class II: Risk

Recall Details

Recall Number
Z-0620-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
10/31/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,770 units

Reason for Recall

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 Description

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

Distribution Pattern

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.

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.