Z-0620-2025 Class II Ongoing
FDA device recall Z-0620-2025 was initiated by Olympus Corporation Of The Americas on Oct 31, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1,770 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 11, 2024
- Initiation Date
- Oct 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,770 units
Product Description
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
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 ).
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.
Code Information
Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0620-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026