This month the United States Food & Drug Administration (FDA) announced a Class I recall on the defective medical device LIFEPAK 15 monitor/defibrillators after the maker of the device discovered that their product could turn on and off without warning. But what is a Class 1 recall and should you be worried about it? Is an FDA Class 1 recall more serious than a Class 2 recall or a Class 3 recall?

Here is how the FDA recall system works:

There are three levels of recall in the FDA’s system. A Class 1 recall is the most serious, a Class 2 recall is the second most serious, and a Class 3 recall is the least serious. However, it is important to understand that all FDA recalls should be taken seriously, as all FDA recalls are announced because of a potential threat to public health and safety.

• A Class 1 recall is the most serious type of recall – and one that should be heeded with the most concern and the quickest action. A Class 1 recall is a recall that involves a medical device or prescription drug that has the potential to seriously injury or even kill a consumer.
• A Class 2 recall initiated by the FDA are recalls that involve products that could cause potential temporary health issues or minor injuries, such as a drug that is not the correct strength or a drug that produces a previously not mentioned, mild, and temporary side effect. Some Class 2 FDA recalls have a small possibility of causing irreversible health consequences.
• A Class 3 FDA recall is the least serious of all three types of recalls and does not present a serious or likely chance of harm to consumers. While these products do not have a serious potential to cause any kind of harm they usually violate FDA regulations in some minor way that requires a recall. An example of a Class 3 recall would be a product that does not correctly advertise the number of pills in the bottle.