Recalls are actions performed by a company to withdraw a product from market. Recalls may be done voluntarily by the company, or by the request of US FDA, or by order of FDA under statutory authority.
Class I recall refers to situation where there is a reasonable probability that the use of or exposure to a hazardous product can result to adverse side effects or even death. Class II recall is where the situation where the use of or exposure to hazardous product can cause temporary or medically reversible severe health consequences or where the possibility of severe health consequences is far. Class III recall refers to a situation where the use of or exposure to dangerous product may not cause severe health consequences.