DermaPen Pro Micro Needling System Recalled for Lack of FDA Clearance
Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is driven by a regulatory compliance issue (lack of clearance) rather than a reported physical hazard or injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Derma Pen, LLC is recalling the DermaPen Pro Model Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. The recall was initiated after the company received an FDA warning letter regarding the distribution of the device without FDA clearance or approval.
The recall affects 1,466 units distributed worldwide, including the United States (nationwide, Puerto Rico, and the Virgin Islands) and 15 other countries. All devices on the market are included in this recall.
Consumers should stop using the product and contact Derma Pen, LLC for further instructions.
The recalled product
- 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.
- Manufacturer
- Derma Pen, LLC
- Affected units
- 1,466
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All devices on the market
Distribution
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