The U.S. Food and Drug Administration (FDA) is responsible for ensuring that certain products, such as medication or medical devices, are safe for patients to use. If a product contains an error that violates FDA law, the manufacturer of the product or the FDA will issue a recall for that product to protect consumers. The FDA classifies recalls in one of three categories based on the defect’s potential to cause serious injuries or health problems.

Class I Recalls

Class I recalls are the most serious and life-threatening of the FDA recalls. If a product contains serious defects that could lead to severe injuries or death, the FDA will likely require the manufacturer to issue a Class I recall. For example, if a medication was contaminated by a poisonous substance during the manufacturing process, the FDA is likely to classify the recall as Class I.

After the recall is issued, the FDA will oversee the process and ensure that the manufacturer takes the necessary steps to protect patients from harm. The manufacturer will submit a recall strategy to the FDA, and the agency will monitor the recall to ensure that the strategy is effective. Once the FDA is able to confirm that the product complies with the law and no longer poses a risk to the consumer, the agency will terminate the recall.

Class II Recalls

The next category is known as a Class II recall. This type of recall is less serious than a Class I, but more serious than a Class III. If a product could cause harm to a patient but only results in a short-term health problem or there is only a slight chance that a serious issue could occur, the FDA will designate the recall as a Class II. The FDA will also oversee the recall process and ensures that manufacturers adequately protect patients from harm.

Class III Recalls

The least serious category of FDA recalls is Class III. If a product’s defect is minor or the error is unlikely to harm a user’s health, the FDA will likely designate the process as a Class III recall. The FDA will also monitor a Class III recall process.

What to Do if You Are Injured by a Defective Product

A defective product can lead to serious injuries and potentially life-threatening complications, especially if it is a medication or healthcare device. If you are injured by a defective medical product, you may have grounds for a lawsuit against the product’s manufacturer. In these situations, it is important to seek help as soon as possible.

  • Seek medical attention and save all records related to your medical care and the nature and extent of your injuries. Continue to receive the treatment that your doctor recommends.
  • Save all evidence related to the defective product, including receipts, empty bottles, prescription records, and other documents that prove that you used the product.
  • Start a journal. Each day, record how your injury has impacted your daily life and your physical, financial, and emotional health.
  • Contact an attorney with experience handling defective drug or medical device lawsuits to discuss your case and legal options.
Spencer Eisenmenger
Helping Kansas City area medical malpractice, product liability, birth injury and personal injury clients.