Reported Sep 16, 2015 · Terminated
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each…
Derma Pen, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Derma Pen, LLC · 3216 Highland Dr Suite 200 · Salt Lake City, UT · 84106-4178
Is this the product you have?
- 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.
- Lot codes and dates
- All devices on the market
- Amount recalled
- 1,466 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
This product could cause temporary or reversible health problems — stop using it.
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