Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19582 |
| Brand Name: | Miramar Labs Mira Dry |
| Model: | |
| Affected: | all batches |
| Software version: | |
| Recalling Organisation: | Device Consulting (NZ) Pty Level 4 52 Symonds Street Auckland 1010 |
| Contact Information: | |
| Manufacturer: | miraDry Inc |
| Issue: | Manufacturer has been advised that some clinics overseas are using substances that have not been validated for use with the miraDry System to lubricate the skin prior to using the miraDry handpiece. This may prevent the cooling plate in the miraDry handpiece from correctly contain and cooling the skin and cause minor burns and blisters. Whilst there have not been any adverse events reported in Australia, Device Consulting is conducting a product correction to update the User Manual for the miraDry System to include the statement: “DO NOT use lubricants other than the recommended lubricants K-Y® Jelly or K-Y® Liquid). Use of other substances such as ultrasound gel or IPL coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.” |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 18/12/2015 |
