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What is a FDA Class Recall?

The Food and Drug Administration (FDA) is responsible for protecting the public’s health by regulating food to make sure it is safe, wholesome, and properly labeled. The FDA makes sure that drugs, vaccines, medical devices, and other biological products are safe and harmless for human and animal use. The FDA also assures that dietary supplements and cosmetic products are safe to use and labeled properly, along with regulating the tobacco industry.

When the FDA discovers that a product or food item can be potentially harmful to a consumer, they will issue a recall on that product. Often times, you will read about these recalls in the newspaper or hear about them on the local news. However, how does one know how serious the recall is and whether or not they should immediately stop using that product? For this reason, the FDA has multiple recall categories divided up based on the severity of the problems with the product.


  • Class I: this is when the FDA determines that there is a high probability that the use or exposure to a violative product will cause serious harm to the user’s health or even death.
  • Class II: when the FDA determines that the use or exposure to a violative product can cause temporary, treatable, or reversible health problems, or the chance of serious or fatal consequences from using the product are remote.
  • Class III: when the FDA determines that the use or exposure to a violative product is unlikely to cause any serious health consequences.
  • Market Withdrawal: When a manufacturer or company removes the product from the market due to a minor problem which they can choose to correct or keep off the market. The minor violation is not subject to FDA legal action.
  • Medical Device Safety Alert: these are issued by the FDA in situations where a medical device can cause an unreasonable or substantial risk of harm to the user. In certain situations, these may also be classified as recalls.


The FDA organizes their recalls in class, with the most dangerous recall being Class I and the least dangerous recall being Class III. As consumers, we expect that the goods we purchase live up to their marketed expectations and be safe for us to use or consume. However, manufacturers are run by humans and there will always be the risk of human error and negligence.

If you, a loved one, or someone you know suffered an injury or a health problem after using a product that was recalled or eventually recalled, it is important you contact an experienced product liability attorney as soon as possible. You may be entitled to compensation for the damages you suffered.

At Sibley Dolman Gipe Accident Injury Lawyers, PA, our attorneys will aggressively fight for you to be properly compensated. We understand that money will not undo the harm you have suffered, however, it will help in the recovery process. We have the resources to take on the largest of corporations and are unafraid to do so. We strongly believe in holding the negligent responsible for the harm they have committed.

For a free and confidential consultation on your case, call Sibley Dolman Gipe Accident Injury Lawyers, PA today at 727-451-6900.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765