Recalls occur when there is a defect in the medical device. This is usually not a theoretical risk, as that would be more obvious and caught in the development stages. It is usually an unexpected health risks or danger that was reported by users. This includes unexpected side effects, such as early drugs that were shown to cause birth defects. Although the companies did clinical trials, they failed to test or properly assess the results on pregnant woman. Or a medical device that is shown to have a negative effect 20 years down the road, there may be no way to catch that with testing. Another possibility is a medical device that was classified as class II but really needed clinical trials so it is recalled and needs to be reclassified. Some recalls are preventable and some just aren’t, and then all action must be done to protect the patients and users.