Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0234-2016 — 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

U.S. FDA — Device Enforcement · United States · 2015-10-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0234-2016
Date of alert: 2015-10-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Miramar Labs, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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