What are the different classes of FDA medical device recalls?

On Behalf of | Nov 11, 2022 | Product Liability

When the U.S. Food and Drug Administration issues a recall of a medical device, it will fall into one of three classes. The classes help to define how dangerous the issue with the device may be to patients.

The FDA classes have simple Roman numerals. They are I, II and III. Each class identifies the risks to the user and alerts healthcare professionals to the potential for serious problems that may result from using the device.

Class I

Class I recalls are the most concerning. Anything under this class could cause serious injury or death to people using the device. It would require immediate attention from the user and that person’s healthcare professional to address the problem.

Class II

Class II recalls are those devices that could lead to a health issue, but the problem will be temporary or something easily corrected in most cases. The chances of a serious injury or death are low but still possible.

Class III

The least dangerous type of recall will fall under Class III. These are situations where the issue with the device will probably not cause any health issues. It is a matter of minor problems but will not lead to death or serious health concerns.

Regardless of the recall class assignment, whenever there is a device recall, doctors should meet with patients to discuss what to do next. Obviously, the more serious recalls will require more attention and quicker response to prevent any potential major health consequences. But all recalls are worth a meeting of the patient and doctor to go over options and to learn more about the device’s issues.


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