FDA Medical devices recall ·
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190… recall
- Recall number
- Z-0620-2025
- Date
- (initiated October 31, 2024)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,770 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Why was it 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 ).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
Distribution
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0620-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.