Lower riskMedical device recall · FDA · Published October 31, 2024
Olympus EVIS EXERA III Gastrointestinal Videoscope Recall: HLD Disinfection Risk
Olympus recalls EVIS EXERA III Gastrointestinal Videoscope model GIF-1TH190 due to unsafe high-level disinfection (HLD) with Acecide-C disinfectant in the OER-Pro reprocessor. Affected units have specific serial numbers or UDI codes.
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 ).
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus EVIS EXERA III Gastrointestinal Videoscope Recall: HLD Disinfection Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53613-olympus-evis-exera-iii-gastrointestinal-videoscope-recall-hld-disinfection-risk. Based on FDA recall #Z-0620-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0620-2025%22&limit=1).
Olympus Corporation of the Americas voluntarily recalled EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 units due to high-level disinfection compatibility issues, according to the FDA on Oct. 31, 2024.
How to tell if you have it
Brand: Olympus
Product: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190
Model Number: GIF-1TH190
UDI: 04953170343360, 04953170437014
Serial Number Range: Before 2446103 or After 2500453
The hazard
High-level disinfection with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Recent brand recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable recall dated 2026-08-27 and an Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall dated 2026-08-24. Other recent recalls of similar products include an Olympus OER-Pro Recall dated 2025-10-31, an Olympus OER-Elite Recall dated 2025-10-31, and an AVID Medical Halyard IV Start Kit Recall dated 2026-07-14.
How to tell if you have this one
Check the serial number on the scope's packaging or label. Affected units have serial numbers before 2446103 or after 2500453. The Unique Device Identifier (UDI) codes 04953170343360 or 04953170437014 also indicate affected units.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on the scope's packaging or label. Affected units have serial numbers before 2446103 or after 2500453.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0620-2025 (October 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0620-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.