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What Do Classifications Mean in Defective Product Recalls?

Florida consumers are always hearing about product recalls in which the U.S. Food and Drug Administration is involved. The FDA regulates a number of products, not all of which are actually food or drugs; however, most are.

These include approximately 80 percent of food products, animal feed, human and animal drugs, vaccines and medical devices. The agency also oversees recalls of cosmetics, products that emit radiation, human tissue used for transplants and blood.

The FDA's role in the recall process varies depending on the company involved and the defect. In most cases, when a company is made aware of a product defect, it issues a recall on its own. In other cases, the FDA will make the company aware of a concern it has, prompting the company to issue a recall. The FDA rarely has to request a recall. Whatever the situation, the FDA still oversees the recall to help ensure that it adequately addresses the problem.

When consumers read about a recall in which the FDA has oversight, they see a classification. There are three classes of recalls, based on how serious the potential harm could be:

  • Class I is the most serious. It is used when a defect could cause serious injury, illness or even death. Some contaminated foods rise to the level of Class I. So do many drug and medical device product defects.
  • Class II is used where the potential harm is unlikely to be serious. However, the defect could cause a health problem. An example is when a drug is not the strength it's reported to be.
  • Class III is used when a product violates manufacturing or FDA labeling laws but is not likely to cause physical injury or illness.

Many recalls come about because one or more consumers experienced a problem and notified the FDA, manufacturer, retailer or someone else involved in the supply chain. By doing this, they may well save others from harm or worse. If a product has caused harm, it may also be advisable to get legal guidance to help get compensation for any medical bills or other damages.

Source: FDA Consumer Health Information, "FDA 101: Product Recalls From First Alert to Effectiveness Checks," accessed April. 20, 2015

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