The U.S. Food and Drug Administration (FDA) has broad authority over many areas, including but not limited to food, dietary supplements, prescription drugs, vaccines, and medical devices, such as surgical implants, prosthetics, dental devices and pacemakers.

In reference to medical devices, the FDA may recall a defective device if it has been shown to harm the public. What is a medical device recall? It's a recall action taken by the FDA to address a problem with a device that violates FDA law.

An FDA recall can occur when:

• A medical device is defective
• The device poses a health risk
• The device is both defective and a health risk

Do recalls mean you stop using the device?

Medical device recalls do not necessarily mean that you stop using the device or return it to the manufacturer. Sometimes a recall simply means that the device needs to be adjusted, fixed, or checked.

If it's an implanted device, such as a hip implant or a pacemaker, it doesn't always need to be removed. However, if an implanted device has the potential to unexpectedly fail, doctors are supposed to contact their patients to discuss the possibility of removing the device.

Examples of actions considered to be recalls:

• Notifying patients of a problem
• Adjusting the settings on a device
• Making repairs to the device
• Re-labeling of the device
• Having the device destroyed
• Monitoring patients for any possible health complications
• Asking to inspect the device for any problems

FDA recalls fall into two categories: corrections and removals. Corrections address a problem with the device where it is used or sold, whereas removals address a problem by removing it from where it is being used or sold.

Though most companies recall defective devices voluntarily, legally speaking, the FDA can require the company to recall the defective device, though in practice that rarely happens; most companies recall them on their own.

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