🔍 RecallPedia

Derma Pen

1 recall •
🏥 Medical Devices
• Categories: Surgical Instruments

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.

Class I - Dangerous

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

Feb 5, 2015 Surgical Instruments Nationwide View Details →