RecallGuardianCanada
Medical devices· Updated December 16, 2021

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

Standard priority
Recalled product: Dr. pen microneedling devices are not authorized for sale and may pose health risks
What you should do
  1. 1Do not use or buy unauthorized Dr. pen microneedling pens and cartridges or receive services at spas or from estheticians using these devices.
  2. 2Consult your healthcare professional if you have used these products, or have had them used on you, and you have health concerns.
  3. 3Only seek microneedling treatment from an experienced professional, as they can assess the benefits and risks of microneedling treatment for your individual health circumstances.
  4. 4Check whether medical devices have been authorized for sale by searching Health Canada's Medical Devices Active Licence Listing (MDALL).
  5. 5Report adverse effects or complaints involving medical devices, including the sale of unauthorized devices, to Health Canada.
The issue

Unauthorized product

Affected 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.

Where it was sold

Canada (national)Reported in the official notice — confirm there.

Issued by

Health Canada

Read the official Government of Canada notice

RecallGuardian ranks, illustrates and rewrites recalls in plain language. The official notice is authoritative — confirm model numbers, lot codes, dates and remedies there.

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