Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36470 |
| Brand Name: | Olympus - Sheaths Laser Sidefire |
| Model: | SHEATH LASER SIDEFIRE OUTER 22.5Fr |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Winter & Ibe GmbH |
| Issue: | In October 2024, Olympus issued a Product Correction in relation to the Cystoscope Outer sheath, 22.5 Fr (Medsafe Ref #33877). The Product Correction Notice instructed users that the Cystoscope Outer sheath should not be used with a GreenLight Laser for BPH therapy until further notice. The manufacturer has received reports about a Cystoscope Outer sheath damaged tip during use of a laser probe. The manufacturer conducted additional testing, which indicated further regulatory actions would be required in order to state compatibility of the cystoscopy sheath with GreenLight laser fibres. Accordingly, and have made the decision to discontinue the product and remove the device from the market. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/1/2026 |
