Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 16, 2015
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.
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Derma Pen, LLC recalled DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for… - a moderate-severity action.
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for… was recalled by Derma Pen, LLC in September 16, 2015. Reason: Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing…. Check the official notice for the remedy. Verify recall #Z-2740-2015 with the FDA Devices before acting.
The recall
Derma Pen, LLC issued this moderate-severity FDA Devices recall-Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- September 16, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2740-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2740-2015) was formally reported on September 16, 2015, with the manufacturer initiating the action on February 5, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Derma Pen, LLC is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 1,466 units.
The documented reason for this recall is: Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Roma…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,466 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2740-2015 |
| Date reported | September 16, 2015 |
| Date initiated | February 5, 2015 |
| Recalling firm | Derma Pen, LLC |
| Firm location | Salt Lake City, UT |
| Affected scope | 1,466 units |
| Distribution | Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, G… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2740-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Derma Pen, LLC. Units affected: 1,466 units.
Why was this product recalled? ▼
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 16, 2015. Severity: Moderate. Recall number: Z-2740-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2740-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 16, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.