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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71149

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

Open FDA event record

Event summary

Timeline bucket
February 05, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Derma Pen, LLC

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

DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

Z-2740-2015
Recall number
Z-2740-2015
Initiated
February 05, 2015
Classification
Class II
Status
Terminated
Recalling firm
Derma Pen, LLC
Quantity
1,466 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.

Code information

All devices on the market

Distribution pattern

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.