EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recallZ-0620-2025 · Olympus Corporation of the Americas · initiated Oct 31, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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 ).
FDA root cause category: Under Investigation by firm
What the company is doing
Olympus notified consignees via letter on about 10/31/2024. Consignees were informed of the issue and of the upcoming revision of the labeling such that the GIF-1TH190 is no longer a compatible endoscope for reprocessing with Acecide-C in the OER-Pro. They were instructed that they would be contacted by their Olympus sales representative within the month to discuss potential OER-Elite and GIF-1TH190 transition programs. Additionally, they were instructed to carefully read the notification, ensure reprocessing staff and other users of the OER-Pro AER are aware of the corrective action, acknowledge receipt of the notification through the Olympus web portal, and to identify and notify recipients of the affected devices if they were further distributed.
Recall details
- Recall number
- Z-0620-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2024
- Posted by the FDA
- Dec 5, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1,770 units
- Product code
- FDS
- FDA submissions
- K232997
- 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.
Product description
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Code information (models, lots, serial numbers)
Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid1 recall85 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K232997 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid19 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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