DermaPen Pro Model — Class II medical device recall Z-2740-2015
Terminated recall by Derma Pen, LLC, reported 2015-09-16, distributed nationwide. Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing
| Recall number | Z-2740-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Derma Pen, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2015-02-05 |
| Classified | 2015-09-05 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2017-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, CO, CR, EC, GB, GR, HK, MX, NL, PE, RO, SE |
| Quantity | 1,466 units |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2740-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.