Z-2740-2015Class II

DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use...

Name: Z-2740-2015 DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use...
Creator: Derma Pen, LLC
Published: 2015-02-05
License: https://open.fda.gov/license/

Derma Pen, LLC / initiated 2015-02-05 / Terminated

FDA source

Derma Pen, LLC began a recall of DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small... on 2015-02-05. FDA classified it as Class II and gives the reason as "Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2740-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Posted: 2015-09-05
Terminated: 2017-01-31
Recalling firm: Derma Pen, LLC
Product: 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.
Product code: PIU
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.
FDA root cause: No Marketing Application
Action: Derma Pen sent a notification letter to its customers on February 5, 2015. The purpose of the notification was to inform customers that the FDA issued a warning letter and the steps Derma Pen was taking to address the FDA' s concerns. For further questions please call (800) 981-5402.
Quantity in commerce: 1,466 units
Distribution: 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.
Product codes and lots: All devices on the market

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2740-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2740-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-05

Product code PIU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)