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Understanding FDA Recall Classification

Posted on in FDA

Our law firm uses this forum to help keep readers informed of U.S. Food and Drug Administration (FDA) recalls. When the FDA does issue a recall, the also 'classify' it – Class I, Class II or Class III, depending on the hazard involved.

But what exactly are the differences between those three FDA recall classifications?

According to the FDA's website, when the agency determines that a product is either defective or potentially harmful, either directly from the manufacturer of the product or by doctor/patient complaints, recalling the product is the most effective way to protect patients.

The majority of recalls are voluntary. Either a company discovers a defective or problem and recalls a product on its own or will announce a recall after the FDA raises concerns. Only in rare cases will FDA request a recall.

A Class I recall is the most serious and is issued when a dangerous or defective product could predictably cause serious injury or death.

A Class II recall is issued when a product might cause a temporary health problem, or pose only a slight threat of a serious nature. An example would be a drug that is not the correct strength or a drug that produces an unrevealed mild and temporary side effect.

A Class III recall is used when products that would probably not cause any adverse side effects, but violate FDA labeling or manufacturing laws. For example, a product that has a minor container defect would fall under this category.

Whatever the class of the recall, it ultimately falls to the FDA to ensure the public's safety and oversee the manufacturer's handling of the recall.

If you've received injuries caused by a defective medical product, you need an Illinois attorney who specializes in defective medical product cases representing you for any compensation you may be entitled to for pain and loss.

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