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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72386

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 09, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Miramar Labs, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0234-2016
Recall number
Z-0234-2016
Initiated
October 09, 2015
Classification
Class II
Status
Terminated
Recalling firm
Miramar Labs, Inc.
Quantity
277 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

MN-MD4000-MC, all units

Distribution pattern

Nationwide Distribution