Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36531 |
| Brand Name: | Celon ENT Electrodes |
| Model: | CelonProBreath - Model - WB990004, WB990007 |
| Affected: | Multiple lot 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: | The manufacturer has identified that certain boxes of CelonProBreath bipolar applicator was released to customers without the required Instructions for Use (IFU) included. Investigation concluded that the cause of the issue was a software configuration error in the packaging process which allowed these devices to be packaged without the IFU. The software configuration error has since been resolved. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/2/2026 |
