FDA Device recall Z-2740-2015
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use
- FDA Device
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use by Derma Pen, citing derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2740-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-05 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Derma Pen |
| Distribution | US |
Product
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.
Reason
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Identifiers
| code_info | All devices on the market |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2740-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.