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Terminated

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.

FDA Recall Z-2740-2015 · Posted 2015-09-05

Recalling FirmDerma Pen, LLC
Recall StatusTerminated
Product CodePIU
Date Initiated2015-02-05
Date Terminated2017-01-31
Product Quantity1,466 units

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.

Firm 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.

Root Cause

No Marketing Application

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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