FDA Classifications for Recalled Products, Including Medical Devices

Residents of the United States are fortunate to have access to top-quality food and health products that go through stringent testing to ensure they are safe for public use. Sometimes, though, products may be defective, requiring them to be recalled. The Food and Drug Administration (FDA) has classified product defects into several different categories and developed implementation plans for companies in the event of a recall.

The majority of recalls in the U.S. are voluntary recalls. This means that the FDA informs a company that there is a product issue that needs to be resolved, and the company chooses to recall the product. Though a recall does not portray a company in the best light, most will voluntarily recall products because bad press relating to a recall is moderate compared to the bad press a company can get from product-related accidents, injuries or deaths. The FDA has limited ability to mandate a recall, but fortunately most companies voluntarily address product issues when notified by the FDA.

Most product recalls for dangerous or defective products fall into one of three categories: class I, class II or class III. Class I recalls are reserved for the most severe product defects. Cargill's recent recall of ground turkey due to salmonella contamination is an example of a class I recall, and was actually the largest such recall in history. Class I recalls also include mislabeling of drugs that may cause immediate harm to a patient.

A class II recall is one that may cause temporary or mild health problems. Most medical device recalls are class II recalls. The highly publicized recall of DePuy Orthopaedics' ASR Hip Replacement system was one such recall. Though the hip replacement system did not cause serious injury or death, it did lead to patient discomfort, bone fracture, dislocation of the joint and subsequent revision surgery, in some cases.

Class III recalls are the lowest severity, reserved for product defects that do not pose a risk to consumers' health, but have labeling or packaging problems that the company needs to fix. For example, a diet soft drink that is mislabeled as regular may be classified as a class III recall.

The FDA can also issue a medical device safety alert if it identifies that a product poses "unreasonable" harm to consumers. In addition, it has mandatory recall procedures it may follow if it identifies a seriously harmful medical device. This type of recall notifies device manufacturers, doctors and patients of the product defect and issues cease of distribution and use orders to manufacturers and medical providers.

FDA recall classifications are designed to help companies identify and resolve product defects before they cause additional, unnecessary harm consumers. If you or a loved one has been injured by a recalled product, please seek the advice of an experienced personal injury attorney in your area to learn about your rights and your options for recovery.