| TGA Action ID |
RC-2026-RN-00024-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus Cystoscope Outer sheath, 22.5 Fr Sidefire
SKU: WA22810A
Serial Number(s): ALL |
| ARTG Number |
146203 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus has received 8 complaints globally about a Cystoscope Outer sheath with a damaged tip during use of a laser probe. Though the risks associated with the use of a Cystoscope with the laser probe have not changed since the related Product Correction (RC-2024-RN-00883-1) in October 2024, Olympus conducted additional testing, indicating further regulatory actions would be required in order to state compatibility of the cystoscopy sheath with GreenLight laser fibres. Accordingly, Olympus has decided to discontinue the product and recall the device from the market.
Olympus has not received any reported injuries related to this matter. |
| Instructions for Customers/Users |
Customers are to:
• Inspect stock immediately and quarantine any stock on hand to prevent further use.
• Complete the Customer Response Form and return it to Olympus.
Once the form has been received, Olympus will reach out to coordinate the return of product and processing of a credit.
This action has been closed out on 30/06/2026 |
| Action Commencement Date |
15/01/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |