Dr. pen microneedling devices are not authorized for sale and may pose health risks
CanadaDr. pen microneedling devices are not authorized for sale and may pose health risks
Recalling Firm: Communications and Public Affairs Branch
Motif du rappel / Danger
TranslatedUnauthorized product
Description du produit & Identification
TranslatedDo not use or buy unauthorized Dr. pen microneedling pens and cartridges or receive services at spas or from estheticians using these devices.Consult your healthcare professional if you have used these products, or have had them used on you, and you have health concerns.Only seek microneedling treatment from an experienced professional, as they can assess the benefits and risks of microneedling treatment for your individual health circumstances.Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).Report adverse effects or complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.What is Health Canada doing?Health Canada continues to follow up with companies (manufacturers, importers, distributors, and retailers) selling unauthorized microneedling devices and to take action on complaints received by the Department. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of these devices into Canada.Related linksSafe medical devices in CanadaBuying medical devices from the internetMedical Devices Active Licence Listing (MDALL)Health Canada reminds that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spas (March 27, 2019)Plasma pens are not authorized in Canada and may pose health risks (November 26, 2018)Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks (September 13, 2019)
Produits concernés
TranslatedDr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions. Sold in various colours and styles.
Additional Source Details
| Field | Value |
|---|---|
| N I D | 63732 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/dr-pen-microneedling-devices-are-not-authorized-sale-and-may-pose-health-risks |
| Issue | Unauthorized product |
| Title | Dr. pen microneedling devices are not authorized for sale and may pose health risks |
| Product | Dr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions. Sold in various colours and styles. |
| Archived | 1 |
| Category | Medical devices |
| Last updated | 2021-12-16 |
| Organization | Communications and Public Affairs Branch |
| What you should do | Do not use or buy unauthorized Dr. pen microneedling pens and cartridges or receive services at spas or from estheticians using these devices.Consult your healthcare professional if you have used these products, or have had them used on you, and you have health concerns.Only seek microneedling treatment from an experienced professional, as they can assess the benefits and risks of microneedling treatment for your individual health circumstances.Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).Report adverse effects or complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.What is Health Canada doing?Health Canada continues to follow up with companies (manufacturers, importers, distributors, and retailers) selling unauthorized microneedling devices and to take action on complaints received by the Department. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of these devices into Canada.Related linksSafe medical devices in CanadaBuying medical devices from the internetMedical Devices Active Licence Listing (MDALL)Health Canada reminds that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spas (March 27, 2019)Plasma pens are not authorized in Canada and may pose health risks (November 26, 2018)Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks (September 13, 2019) |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Dr. pen microneedling devices are not authorized for sale and may pose health risks?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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