Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36438 |
| Brand Name: | Resectoscope Resection Sheaths |
| Model: | RESECTION SHEATH and INNER SHEATH |
| Affected: | Multiple lots |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Winter & Ibe GmbH |
| Issue: | The manufacturer has identified complaints related to the ceramic tip of the resection/inner sheath breaking. There were reports, where the tip fell off during the procedure. In most events, the clinician identified and retrieved the fragment during the procedure. By nature, ceramics are not pliable and may fracture unexpectedly under significant mechanical impact. The manufacturer' investigation revealed that some devices remain in use for prolonged periods and may be subjected to stress over their operational lifetime. The manufacturer is highlighting the importance of strictly adhering to the 'Inspection and Testing' and 'Caution' sections in the IFU for the resection/inner sheath, as well as the 'Inspection Before Each Use' section in the Resectoscope System Manual. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/1/2026 |
