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Health Canada advised that the Philaser Type 2.0 device is considered a class III medical device and requires a licence.  The Philaser Type 2.0 device is not currently licensed, so we have stopped sales and advertisement of the Philaser Type 2.0…

Recall being conducted as the device does not have a medical device licence in Canada and due to design flaw. Recall start date: March 27, 2023

Rockdoc was unaware that providing individual medical devices from a licensed or authorized group of test kits to patients was in contravention of Canadian medical devices regulations. Specifically, the format in which the devices were provided to…

Sale of unlicensed class III NovaThreads devices under the name Sutura medical devices. Sutura Medical Technology will be performing a recall notifying customers of the circumstances and termination of sales. Recall start date: November 28, 2022

Hi-Tec Implants doesn't have a valid Health Canada license for their medical devices of class II and III as of Dec 7 2020. The list of devices is non-exhaustive; no devices manufactured by Hi-Tec Implants are licensed at the time of this recall.…

The recall is being done because the device does not meet the requirements of the MDR. Specifically, the devices implanted are not on the device system's active license 104252. Recall start date: March 1, 2023

The supplied products have been exported to Canada without license from Canadian authorities.  Recall start date: February 01, 2023

Momcozy wearable breast pumps were sold in the Canadian market without the proper authorization (i.e., medical device licence [MDL]). Recall start date: January 28, 2023

Non-licensed inventory was sent to Canada via web shop orders starting in February of 2022. Recall start date: December 12, 2022

Product was sold after device licence expired on March 31 2022. Recall start date: December 06, 2022

Importation and sale of an unlicensed class II medical device. Recall start date: December 20, 2022

Following a medical device reclassification from MDD of the device , the company Fotofinfer System, Inc  has decided to cease selling the Fotofinder ATBM Master in Canada and notify customers.  Recall start date: October 21, 2022

Health Canada is warning that ozone saunas may pose serious health risks to users and to anyone in close proximity. In Canada, ozone saunas require a medical device licence from Health Canada to be imported and sold. To date, Health Canada has not…

It has been identified that the Invisus SLP Ultrasound product is not registered to be sold in Canada, as there is no Canadian license for this part. Natus is not able to sell the Invisus SLP Ultrasound product into Canada and as part of this field…

Ecotest Covid-19 Antigen Rapid Test Devices were sold without having the proper authorization from Health Canada. Recall start date: August 11, 2022