Z-0234-2016Class II

miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT...

Name: Z-0234-2016 miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT...
Creator: Miramar Labs, Inc.
Published: 2015-10-09
License: https://open.fda.gov/license/

miraDry, Inc. / initiated 2015-10-09 / Terminated / root cause: labeling and UDI

FDA source

Miramar Labs, Inc. began a recall of miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic... on 2015-10-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0234-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-09
Posted: 2015-11-06
Terminated: 2015-12-23
Recalling firm: miraDry, Inc.
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.
Product code: OUB Instrument For Treatment Of Hyperhidrosis
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Miramar Labs sent Medical Device Correction letters to all users on October 9, 2015 to inform them of the labeling clarification by UAPS First Class Certified mail or courier such as Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the firm added a new warning to their labeling. The firm included an updated copy of the MD4000-MC User Manual with the new warning included and asked that customers destroy their older copy. Customers with questions were instructed to call Customer SService at 1-855-647-2379 or email [email protected]
Quantity in commerce: 277 units
Distribution: Nationwide Distribution
Product codes and lots: MN-MD4000-MC, all units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0234-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0234-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code OUB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)