From doing some reading on the FDA website a ‘recall’ is when a manufacturer takes a correction or removal to address a problem with a medical device that violates FDA law. The first action called “correction” address a problem with a medical device in the place where it used or sold. This could be applicable to the type of action the actual device is intended for. For example maybe a medical device is actually considered a drug or biologic which end up changing the bodies chemical properties. The other action is removal which addresses a problem with a medical device by removing it from where it is used or sold. The severe case this is applied to is when deaths start occurring. Recalls happen for many reasons. The FDA is strict but that does not mean they will be able to prevent every problem that arises. For example metallosis from hip stems is a chronic issue they did not know such things would happen until it was placed in the body.