Celon Ent Electrodes
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Celon ENT Electrodes. [Device]. Model: CelonProBreath - Model - WB990004, WB990007. Affected: Multiple lot numbers
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-09
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d5e5c70c-2dbb-4891-a467-1e9fde780ede