An FDA recall is when the Food and Drug Administration (FDA) authorizes the removal of a product from distribution in the market. Such a recall may be initiated through a request by the FDA, or through the FDA exercising its statutory authority to have the product recalled. The recall may affect the product in several ways, such as its being corrected by the manufacturer, or it being discontinued as a whole.

What Are FDA Recall Classes?

FDA Recalls can be classified into three classes:

  • Class I: There is a “reasonable probability” that exposure to or use of the product will result in death or serious adverse health consequences
  • Class II: Use of/exposure to the product may cause temporary or medically reversible adverse health consequences; in other words, the probability of serious, adverse health consequences is remote
  • Class III: Use of or exposure to the product is not likely to cause adverse health consequences

Class I recalls involve the most serious injuries and risks, while Classes II and III involve less serious risks. The FDA may also issue “medical device safety alerts,” which inform the public of dangerous medical devices. These alerts can sometimes be considered recalls.

What Items Are Commonly Subject to FDA Recalls?

FDA recalls are commonly issued for products that present immediate dangers to the public, such as dangerous foods, unsafe drugs, and other similar products. The FDA may also issue recalls for non-food or drug items such as medical devices including medical implants, cosmetics, toxic substances, and radiation-emitting objects.

What If I Have Been Injured by a Product That Was Subject to an FDA Recall?

In some cases, the fact that a product was recalled can provide evidence that it was dangerous and can bolster an injured person’s legal claim. In fact, most FDA recalls occur because many persons are being injured or adversely affected by the same product. In such cases, those injured by the product may be entitled to legal compensation for economic losses caused by the product. A damages award can often provide compensation for medical expenses, hospital bills, and other costs.

Damages may be limited according to various factors, such as differences in state laws, and whether or not the lawsuit is filed as a class action. When calculating damages, the court may take into consideration the date of the recall, and whether or not the person had knowledge that they were using a recalled product (i.e., whether they were assuming the risk of injury).

Do I Need a Lawyer for Help with FDA Recall-Related Injuries?

Dangerous products can often lead to serious injuries or medical complications. You may need to hire a personal injury lawyer in your area if you have been injured by an FDA-recalled item. FDA recalls are subject to constant change are frequently updated. Your lawyer can help research the laws to determine which legal remedies might apply to you, and what you can do to obtain legal relief. Also, if you need to file a lawsuit, your attorney can represent you during the legal process.