Medical Device Recalls in Canada

A medical device recall is an official notice that equipment used for medical purposes may not work correctly, could cause harm, or doesn't meet safety standards. This includes items like pacemakers, insulin pumps, diagnostic equipment, surgical tools, implants, monitors, and hospital supplies. Health Canada issues these recalls to protect patients and healthcare providers. Medical device patient guide →

Contact your healthcare provider or the company that made the device as soon as possible. Do not stop using essential medical equipment without medical advice, as this could be more dangerous than the recall issue. Your healthcare team can help you understand the risks and arrange for repairs or replacements. What to do when a product is recalled →

Healthcare providers should contact the device manufacturer or distributor listed in the recall notice. They can also reach Health Canada's Medical Devices Directorate for guidance. Facilities should have processes for identifying affected equipment and notifying relevant patients.

Not all recalls involve immediate safety risks. Health Canada classifies recalls by severity. Class I recalls involve serious health risks or death, Class II recalls may cause temporary health problems, and Class III recalls are unlikely to cause health problems. Always read the specific recall notice for guidance.

Health Canada uses a three-tier classification: Class I is the most serious, involving potential for serious health consequences or death. Class II may cause temporary or medically reversible health problems. Class III is unlikely to cause health problems but violates regulations. The classification helps prioritize response. How recalls work in Canada →

Model and serial numbers are usually on a label attached to the device, on the original packaging, or in the user manual. For implanted devices, your healthcare provider should have records. The recall notice will specify which models and serial numbers are affected.

It depends on the severity of the recall. For some recalls, continued use under medical supervision may be safer than sudden discontinuation. Your healthcare provider will advise you based on the specific recall and your medical needs. Always follow the guidance in the recall notice.

You can confirm official medical device recalls on the Health Canada website or by contacting Health Canada directly. Be cautious of unofficial sources. Healthcare providers and facilities also receive direct notifications about recalls affecting their patients. How to check for recalls →

Seek medical attention immediately if you suspect injury from a recalled device. Document everything including the device information, symptoms, and medical treatment. Report the incident to Health Canada through the Medical Device Problem Reporting process. What to do if injured by a recalled product →

You can sign up for email alerts to receive notifications when new medical device recalls are announced. This is useful for patients who use medical devices and healthcare professionals who need to stay informed. How to get recall alerts →