Medical Device Recalls in Canada: A Patient Guide
If you use a medical device—whether it's an implant, insulin pump, or home monitoring equipment—this guide explains what happens when devices are recalled and what you should do.
What Is a Medical Device Recall?
A medical device recall is an action taken to address a problem with a device that violates federal regulations or could pose a health risk. In Canada, Health Canada oversees medical device safety and publishes recall notices.
Medical devices range widely—from tongue depressors and bandages to pacemakers and MRI machines. You can browse current medical device recalls to see what's been recalled recently.
Not All Recalls Mean "Stop Using"
Some recalls involve software updates, labelling corrections, or enhanced monitoring—not necessarily removal of the device. The specific action depends on the nature and severity of the issue.
Recall Classifications Explained
Health Canada classifies medical device recalls into three types based on the level of health risk:
Type I (Most Serious)
Reasonable probability that use of the device will cause serious adverse health consequences or death. Immediate action required.
Example: Heart valve with potential to fracture; infusion pump delivering incorrect doses.
Type II (Moderate)
May cause temporary or medically reversible adverse health consequences. Low probability of serious outcomes. Action needed, but typically less urgent.
Example: Blood glucose monitor with accuracy issues; diagnostic test with false positives.
Type III (Least Serious)
Unlikely to cause adverse health consequences. Often involves labelling issues, minor quality problems, or violations that don't affect safety.
Example: Missing instructions; incorrect expiry date printed on packaging.
How You'll Be Notified
Notification methods depend on the type of device and severity of the recall:
Implanted Devices
Your surgeon or specialist's office should contact you directly. Hospitals maintain registries of patients with certain implants.
Prescription Devices
Your prescribing physician or the medical supply company may notify you. Pharmacies may also reach out for certain devices.
Over-the-Counter Devices
For devices purchased directly (blood pressure monitors, thermometers, etc.), you'll need to check recall notices yourself or register your product with the manufacturer.
To learn how the recall process works, see our guide on how product recalls work in Canada.
What to Do as a Patient
- 1Don't panic
Read the recall notice carefully. Many recalls don't require immediate action or device removal.
- 2Contact your healthcare provider
They can explain what the recall means for you specifically and recommend next steps.
- 3Follow instructions in the recall notice
This may include scheduling a check-up, getting a software update, or returning the device.
- 4Keep the device until instructed otherwise
Don't dispose of a device before getting guidance—it may be needed for investigation or exchange.
- 5Report any problems
If you've experienced issues with the device, report them to Health Canada and your healthcare provider.
Special Considerations for Implants
Implanted medical devices (pacemakers, joint replacements, surgical mesh, etc.) require special consideration during recalls:
Removal vs. Monitoring
Removing an implant carries its own risks. For many recalls, the recommended action is increased monitoring rather than surgery. Your doctor will weigh the risks of the device issue against the risks of removal.
Know Your Device
Keep a record of your implant's manufacturer, model number, and serial number. Ask for this information after any procedure involving an implant.
Implant Cards
You should receive an implant card with device details. Carry it with you and provide it to any healthcare provider who treats you.
Staying Informed
Proactive monitoring helps you stay on top of device safety:
- Register your devices: Fill out manufacturer registration cards for any medical devices you use at home
- Sign up for alerts: Get free recall alerts to be notified about medical device recalls
- Keep records: Maintain a list of devices you use, including model and serial numbers
- Ask questions: When prescribed a device, ask about the recall history of that model
Common Questions
How do I find out if my medical device has been recalled?
Your healthcare provider should contact you if a device you use is recalled. You can also search the Health Canada recall database yourself, check manufacturer websites, or sign up for recall alerts at Recall Guide to receive notifications.
Can I continue using a recalled device?
It depends on the recall classification and specific instructions. Some recalls require immediate removal, while others may allow continued use with monitoring or software updates. Always follow your healthcare provider's guidance.
Who pays for replacing a recalled medical device?
The manufacturer is typically responsible for costs associated with recalls, including device replacement. For implants, provincial health insurance usually covers necessary medical procedures. Contact your healthcare provider and the manufacturer for specifics.
Disclaimer: This guide provides general information only and is not medical advice. Always consult with your healthcare provider about decisions related to your medical devices.
Medical device recall information is published by Health Canada. Visit Health Canada