FDA recall classification (Class I, II, III)
FDA's rating of how serious a recalled product's problem is. Class I is a situation where there is a reasonable probability that using the product will cause serious adverse health consequences or death; Class II is where use may cause temporary or medically reversible adverse health consequences, or the chance of a serious outcome is remote; Class III is where use is not likely to cause adverse health consequences. The class describes the hazard, not the size of the recall.
Example
A Class II recall for an undeclared allergen and a Class III recall for a labeling error can both involve the same number of bottles.