Official recall record
Evis Exera III Video System - Gastrointestinal Videoscope (ref 74508)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-11-01
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The GIF-1TH190 reprocessing manual has instructions for either High Level Disinfection (HLD) reprocessing or Ethylene Oxide Gas (EOG) sterilization after endoscope cleaning. As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization following the GIF-1TH190's reprocessing manual. As a result of the subsequent investigation, Olympus determined that changes are required to the endoscope's channel drying steps following cleaning and prior to EOG sterilization in order to ensure effective endoscope sterilization. Accordingly, Olympus has updated the instructions for the endoscope channel's drying process and validated that the new, updated channel drying steps will result in GIF-1TH190 endoscope EOG sterilization. The revised instructions for the "dry the endoscope" in chapter 5.7 of the GIF-1TH190 reprocessing manual are provided in a supplied addendum. Recall start date: October 11, 2023
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.