FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for recall, whether firm-initiated or requested by FSIS, and classifies the concern as one of the following:

1. Class I. This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. For example, the presence of pathogens in ready-to-eat product or the presence of E. coli O157:H7 in ground beef.
2. Class II. This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product. For example, the presence of undeclared allergens such as milk or soy products.
3. Class III. This is a situation where the use of the product will not cause adverse health consequences. For example, the presence of undeclared generally recognized as safe non-allergen substances, such as excess water.