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Miramar Labs, Inc. recalls miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip an
Recalled November 18, 2015 · FDA recall Z-0234-2016 · Miramar Labs
Hazard
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. · FDA Class II
Units
277 units
Sold at
Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Miramar Labs, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →