Unauthorized blood glucose (sugar)-reading smartwatches — recall 74673

Reported risk: Health Canada is warning people with diabetes and parents/caregivers of people with diabetes that various social media and online retail platforms are promoting unauthorized blood glucose-reading smartwatches. These devices have not been assessed for safety and effectiveness and may pose serious health risks to consumers because they may give false blood glucose readings or they may not provide timely alerts, which could lead to errors in diabetes management. Health Canada has authorized devices to be inserted under the patient's skin that can be used with their smartwatch or smartphone to monitor blood glucose levels. Authorized devices can be found by searching Medical Devices Active Licence Listing (MDALL ). Health Canada has not authorized any smartwatches that can independently monitor blood glucose levels. If a false blood sugar reading is used to make diabetes treatment decisions or an important alert is not provided in time, serious errors can occur such as: taking too little insulin, which can lead to high blood sugar (called hyperglycemia), taking too much insulin, which can lead to low blood sugar (called hypoglycemia), and failing to treat low or high blood sugar. These serious errors can lead to health consequences requiring medical treatment, such as hyperglycemic emergencies, severe low blood sugar, loss of consciousness, seizure, coma, and death. Health Canada will take necessary action to stop the sale and advertisement of unauthorized blood glucose-reading smartwatches in Canada. The Department's compliance and enforcement approach is to mitigate the risk to Canadians using the most appropriate level of intervention, in accordance with our Compliance and enforcement policy for health products .