| TGA Action ID |
RC-2025-RN-00659-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Evis Exera III Gastrointestinal Videoscope and Evis Exera III Colonovideoscope
Model numbers: GIF-HQ190, CF-HQ190L, CF-HQ190I
Product codes: N3802940, N3802140, N3802240
Lot numbers: 20209903, 20209905, 20210594
Multiple serial numbers |
| ARTG Number |
355250, 355634 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Olympus identified holes in the sterile packaging for some GIF-HQ190 and CF-HQ190L/I endoscopes during post-sterilisation inspection. They are inappropriately labelled as “STERILE” due to the potential for holes in the sterile packaging. The holes in the sterile barrier are caused by the endoscope piercing the pouch.
The endoscopes affected do not require sterilization for safe patient use. Reprocessing standards require only high-level disinfection. The subject endoscopes were appropriately cleaned, high-level disinfected, and passed microbiological testing.
No complaints have been identified relating to this matter. Olympus is recalling unopened units out of an abundance of caution. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine any affected devices that are still in the sterile packaging
- Return any of the Olympus On Demand loaner endoscopes(s) listed in Appendix A that are still in the sterile packaging
No action is required for endoscopes that have already been removed from the sterile packaging.
This action has been finalised on 18/12/2025. |
| Action Commencement Date |
29/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |