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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 09, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-0234-2016
Recall Event ID 72386
510(K)Number K103014  K131162  K150419  
Product Classification Instrument for treatment of hyperhidrosis - Product Code OUB
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.
Code Information MN-MD4000-MC, all units
Recalling Firm/
Miramar Labs, Inc.
2790 Walsh Ave
Santa Clara CA 95051-0963
For Additional Information Contact Kathy O'Shaughnessy, PhD
Manufacturer 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.
FDA Determined
Cause 2
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 info@miraDry.com
Quantity in Commerce 277 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OUB and Original Applicant = MIRAMAR LABS, INC.