FDAOctober 9, 2015device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
miramar labsmiramar
Recall history
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