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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
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
The hazard
Dr. Pen microneedling devices are not authorized for sale and may pose health risks
How to check if you're affected
How to check if you're affected
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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 & status
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Recall details
Recall details
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Documents, notices & source
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