Miramar Labs, Inc. recalls miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip a…

Recall date

October 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0234-2016

FDA classification

Class II

Brand / firm

Miramar Labs, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.