Product recall Class II

Class II recall is the situation in which 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. It is preventative in nature and issued if there is no immediate danger of death or other serious injury linked to the product.

Examples of Class II recalls include
*Botulinum potential and Norovirus contamination in seafood
*The presence of undeclared dry milk as an ingredient in sausage,
*A food that contains yeast or mold contamination
*Candy with FD&C #5 yellow dye not listed on the label
*Metal shavings in a canned food.

FDA recall classifications are designed to help companies identify and resolve product defects before they cause additional, unnecessary harm consumers. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Product recall Class II

Product recall Class I

Recalls are an effective method for removing or correcting marketed products, their labeling, and/or promotional literature that violate the laws administered by the Food and Drug Administration (FDA).

The FDA recall classifications range from Class I (most severe) to Class II (moderately severe) and Class III (least severe).

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

Examples: Product tampering or mislabeling of a lifesaving drug; foods that are found to contain the toxin causing botulism, foods contaminated with very pathogenic pathogens (including but not limited to Listeria monocytogenes, Salmonella or pathogenic E. coli); or a food that contains one of the eight (the Big‐8) common allergens but is not properly labeled to indicate the presence of these allergens.
Product recall Class I

Classification of defects: critical defect

A classification of defects is the enumeration of possible defects of the unit of product classified according to their seriousness. Quality defects are classified into three broad areas: critical, major, and minor.

A critical defect is a defect that is likely to result in a hazardous or unsafe condition for an individual or anyone around him using the product or that contravenes mandatory regulations.

The most serious critical defects are those which can endanger the health of consumers - contamination by toxic chemicals, salmonella, botulism, metal or ceramic fragments and so on.

Any product is usually subject to 100 percent inspection for critical defects. Because of this requirement, the monitoring of CCPs is monitoring of CCPs is different from that of many other important but less critical factors in food process.
Classification of defects: critical defect

Product Recall: Policy and Classification

Product Recall: Policy and Classification
Recall Policy
There are basically three types of recall policies

• Voluntary recalls are the most common method of effectively removing or correcting consumer products in violation of FDA and USDA regulations.

• Recalls may be requested by the regulatory agencies due to the product being harmful, a risk to the public, or out of compliance with food regulations.

• Product seizures occur when manufacturers refuse to recall a product or when the recall is ineffective and the violation continues.

Recall Classification

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

• Class II recall is the situation in which 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.

• Class III recall is the situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Product Recall: Policy and Classification