Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23315 |
| Brand Name: | Muse_Halo2_Z-Series (BTE) |
| Model: | Model - EM2108 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Starkey Laboratories New Zealand Unit 1, 710 Great South Road Penrose Auckland 1061 |
| Contact Information: | |
| Manufacturer: | Starkey Laboratories Inc |
| Issue: | It has recently been reported that an unattended child aged 7 months has required treatment to remove an earmould from the larynx. To ensure the safeguarding of the products the manufacturer has taken new steps to further improve the safety of the earmoulds for young children and have implemented a successful method of securing a tube into a Silicone earmould with a bonding glue to prevent the detachment of the earmould. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 11/7/2018 |
