Miramar Labs, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0234-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 9, 2015

Date Posted: November 18, 2015

Recall Number: Z-0234-2016

Event ID: 72386

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.

Status: Terminated

Product Quantity: 277 units

Code Information:

MN-MD4000-MC, all units

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated