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Understanding FDA Recall Categories

By August 19, 2014January 29th, 2022Dangerous Drugs

A Food and Drug Administration recall may be necessary when a drug or food product turns out to be dangerous.  A recall means that the product is removed from the market and/or an alert is sent out to the public to warn them of the dangers that the product presents to their health and safety. 

There are different categories of FDA recalls depending upon the severity of the risk that a product presents.  It is important to understand the categories and to be aware of recalls that occur so you do not accidentally continue to use a product that has been found to be dangerous. If a recall occurs and you believe you were harmed by the product before it was taken off the market, then you need to act. Carey, Danis & Lowe represents clients who are the victims of defective drugs and dangerous medical devices in the St. Louis area. We can help you to pursue a claim for compensation if you were harmed by a product that has been subject to an FDA recall.

FDA Recall Categories

There are three primary FDA recall categories:

  • Class I recalls are the most serious.  A Class I recall will occur if a product presents a substantial risk of serious and/or permanent harm to a patient’s health. For example, if a drug is suspected of causing cancer or a heart attack, a Class I recall may be appropriate.
  • Class II recalls are reserved for situations where there is a risk the product will cause minor medical harm or reversible medical harm. A Class II recall is appropriate if the chances of severe and/or permanent damage to health is very unlikely to occur.
  • Class III recalls are reserved for situations when using a product is not likely to have an adverse impact on health. If a product needs to be recalled due to a problem but its use is not likely to make patients sick, this is the appropriate type of recall.
  • Medical Safety Device Alerts may accompany a recall or may stand alone. The FDA will issue a Medical Safety Device alert if it believes that a medical device being sold to consumers may have side effects or risks that patients are not being adequately warned about.

The FDA can initiate a recall if it believes that consumers are at risk.  The manufacturer may also issue a voluntary recall if the company that makes a drug, medical device or other product believes that there is a danger associated with its use.

Getting Legal Help After an FDA Recall

When the FDA recalls a product or a manufacturer voluntarily recalls a product, this is a sign that there are serious concerns about the safety of the drug, device or other product.  If you or a loved one has been using the product and you have suffered an adverse reaction, you may wish to pursue legal action. The recall can help you to make your case that something was wrong with the product and that the manufacturer should be held accountable.

Contact a St. Louis defective product lawyer at Carey, Danis & Lowe after a recall to learn more about your options.