Derma Pen, LLC: Medical Device Recall in 2015 - (Recall #: Z-2740-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 5, 2015

Date Posted: September 16, 2015

Recall Number: Z-2740-2015

Event ID: 71149

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.

Status: Terminated

Product Quantity: 1,466 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated