No image published for this recall

No image published for this recall

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.

Official notice

16 Dec 2021

Last checked

16 Dec 2021

Risk not stated by sourceHealth Canada

An official Health Canada notice concerns 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.. Dr. Pen microneedling devices are not authorized for sale and may pose health risks Published 2021-12-16.

What to do now

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)

Recall number

63732

Official notice

2021-12-16

The hazard

Dr. Pen microneedling devices are not authorized for sale and may pose health risks

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63732

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Dr Pen Auto Microneedle System All Models Including But Not To A1 A6 A7 A6s E30 M5 M7 M8 N2 And X5 And Ultima Versions Sold In Various Colours And Styles.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

App estimate

unspecified

Recall details

Recall number

63732

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 16 Dec 2021. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.