Major Recalls of Organ Replacement Devices

What Is a Recall?

An FDA recall is issued when a medical device violates FDA law. Such a violation will occur when a device becomes defective or could be a risk of health. A number of actions can be taken that would constitute a recall. Some of these actions include repairing the device, inspecting the device, adjusting settings on the device, or notifying the patients of a problem. Once a device is recalled, the FDA classifies it into three categories: class I, class II, and class III.

What is a Class I recall?

This category includes devices that could potentially cause serious health problems or death to the patients.  The company then must notify the customers and all intended recipients of the device. Press releases by the company and the FDA are then made to notify the public.

What is a Class II recall?

This category includes devices that could pose temporary or reversible health problems to the patients. The company must then notify the customers and might notify its intended recipients of the device.

What is a Class III recall?

This category includes devices that pose little or no health problems to its patients. The company must then notify the customers.

Last Updated: April 30, 2007