miraDry System consisting of the MD4000-MC Console — Class II medical device recall Z-0234-2016
Terminated recall by Miramar Labs, Inc., reported 2015-11-18, distributed nationwide. Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to
| Recall number | Z-0234-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miramar Labs, Inc., Santa Clara, CA, United States |
| Recall initiated | 2015-10-09 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2015-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 277 units |
| Reason classes | labeling |
Product
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
Reason for recall
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0234-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.