Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DermaPen Pro Model Recalled by Derma Pen, LLC Due to Derma Pen initiated a field communication for Dermapen...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Derma Pen, LLC directly.
Affected Products
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.
Quantity: 1,466 units
Why Was This Recalled?
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Derma Pen, LLC
Derma Pen, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report