A recall is a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers, and against which the FDA would initiate legal action (e.g., seizure). Recalls do not include market withdrawals. FDA assigns a numerical designation (I, II, or III) to a particular product recall to indicate the relative degree of health hazard presented by the product.

A Class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

A Class II recall is a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

A Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences (30).