Health Canada has announced a recall for specific lots of a widely used continuous glucose monitoring system, warning that the devices may provide patients with inaccurate blood sugar readings. The recall, issued on December 5, 2025, targets the FreeStyle Libre 3 Plus sensor manufactured by Abbott Diabetes Care.
Details of the Recalled Medical Device
The recall involves specific sensors from the FreeStyle Libre 3 Plus product line. These small, wearable devices are crucial for individuals with diabetes, as they continuously measure glucose levels through a sensor placed under the skin, transmitting data to a smartphone or reader. The identified flaw could lead to the display of incorrect glucose values, posing a significant health risk. Patients relying on faulty data could make inappropriate treatment decisions, such as administering incorrect insulin doses, potentially resulting in dangerous hypoglycemia or hyperglycemia.
Immediate Actions for Patients and Healthcare Providers
Health Canada is urging all users of the FreeStyle Libre 3 Plus system to immediately check the lot number of their sensors against the recall notice published by the regulator and Abbott Diabetes Care. The agency advises patients not to use sensors from the affected lots and to contact their healthcare provider for guidance on alternative monitoring methods. Pharmacists and diabetes educators are also being alerted to stop dispensing the recalled lots and to inform their patients.
Abbott Diabetes Care is coordinating the return and replacement of the defective units. Patients are instructed to use the contact information provided in the official recall communication to arrange for a replacement sensor. In the interim, individuals are strongly encouraged to have a backup method for checking blood glucose levels, such as traditional fingerstick blood glucose meters.
Broader Implications for Medical Device Safety
This recall underscores the critical importance of post-market surveillance for medical devices in Canada. While Health Canada reviews devices for safety before they are sold, ongoing monitoring is essential to catch issues that arise during real-world use. The recall notice did not specify how many units are affected in Canada or whether any adverse health events have been reported in connection with the faulty readings.
For individuals managing diabetes, consistent and accurate glucose data is non-negotiable. This event serves as a reminder for patients to remain vigilant about device alerts and official communications from both manufacturers and health authorities. It also highlights the need for having a contingency plan when relying on technology for chronic disease management.
