EVIS EXERA III Videoscope (Olympus) – disinfection compatibility issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model Number: GIF-1TH190, UDI: 04953170343360, 04953170437014, Serial Number Range: Before 2446103 or After 2500453
Products Sold
Model Number: GIF-1TH190; UDI: 04953170343360, 04953170437014; Serial Number Range: Before 2446103 or After 2500453
Olympus Corporation of the Americas is recalling EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 due to High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 ).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026