Medical Device Recall Class Type

Know about your medical device implant. Here is the recall class breakdown.

An FDA “Class I Recall” is the most urgent type of recall that the FDA will issue.

In an FDA Class I Recall, there is significant and immediate danger of death or other serious injury from the use of the product being recalled. Class I recalls are pretty rare, but they should be obeyed as soon as you become aware of them. In the case of Class I Recall, the FDA will develop an individual plan that is specific to the manufacturer and the product involved, to make sure that compliance with the recall is complete and that the recall of the items involved is trackable. The objective here is to be sure that all of the affected items are removed from the market, and from people’s homes.

An FDA “Class II Recall” is an intermediate threat level recall.

A Class II recall is issued where there is no immediate danger of death or other serious injury linked to the product, but the risk of death or a serious injury is still present. A Class II recall is more preventative in nature, but there are still health and safety risks involved. As in a Class I recall, the FDA will work with the manufacturer to help get the word out about the recall, as well as to create a plan to make sure that all of the recalled items are pulled from the market as quickly as possible.

An FDA “Class III Recall” is the least serious of all recalls.

A Class II recall is typically issued where there is no immediate or perceived danger of any health issues, but where items have been released that are in violation of FDA regulations. An example of a Class III Recall is the 2010 recall of children’s medicines that were potentially contaminated with small pieces of plastic during the manufacturing process.