FDA Recalls: How to Stay Informed About Unsafe Products

Unsafe product recalls are alarmingly common. While all companies have a legal obligation to ensure that their products are safe for use or consumption, companies fail to meet this obligation far too often.

In many cases, unsafe products will be recalled. As the U.S. Food and Drug Administration (FDA) explains, a “[r]ecall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the FDA.” Unfortunately, many recalls don’t come until it is too late, and this leaves many consumers, patients and families in need of an experienced unsafe product lawyer who can help them assert their legal rights.

Here is an overview of what you should know about FDA recalls:

What Types of Products Does the FDA Recall?

As its name suggests, the FDA only regulates certain types of products—although the scope of its enforcement authority is broader than it may initially seem. Under the federal Food, Drug and Cosmetic Act, the FDA has the authority to request and oversee recalls involving:

• Animal and Veterinary Products
• Biologics
• Cosmetics
• Dietary Supplements
• Drugs
• Food Products
• Fresh and Frozen Foods
• Medical Devices
• Radiation-Emitting Products
• Tobacco

A wide range of products fall into each of these categories—and all of them have the potential to be unsafe if they are not designed, manufactured, shipped or stored properly. For example, biologics can range from vaccines to gene therapy technologies, while medical devices can range from joint replacement implants to surgical mesh.

Understanding the Three Classes of FDA Recalls

When you learn about a recall involving an FDA-regulated product that you or a loved one has purchased or used, there are several pieces of information you need in order to make informed decisions about your next steps. One of these pieces of information is the “Class” of the recall.

The FDA divides recalls into three Classes. All recalls (whether initiated by the FDA or by a manufacturer or distributor) will be placed into a Class by the FDA. The three classes of FDA recalls are:

• Class I – Class I recalls are the most serious. If the FDA declares a Class I recall, this means that, “there is a reasonable probability that the use of, or exposure to, [the recalled] product will cause serious adverse health consequences or death.”
• Class II – If the FDA declares a Class II recall, this means that either: (i) “use of, or exposure to, [the recalled] product may cause temporary or medically reversible adverse health consequences;” or, (ii) “the probability of serious adverse health consequences [resulting from use of the recalled product] is remote.”
• Class III – Class III recalls are the least serious. If the FDA declares a Class III recall, this means that, “use of, or exposure to, [the recalled] product is not likely to cause adverse health consequences.”

Another key piece of information is the nature of a recall. Contrary to popular belief, not all recalls result in unsafe products being pulled from retailers, pharmacies, or healthcare providers’ shelves. While some recalls involve removals or market withdrawals (when a manufacturer stops selling a product completely), recalls can also involve “corrections” that simply result in updates to a product’s instructions or labeling.

How to Find Information About FDA Recalls

How can you find out if an unsafe product is subject to an FDA recall? One option is to search for the product on recalls.gov. This is a database of all unsafe products that are subject to known recalls—including not only recalls issued by the FDA, but recalls issued by the U.S. Consumer Product Safety Commission (CPSC), U.S. Department of Agriculture (USDA), National Highway Traffic Safety Administration (NHTSA) and other federal agencies as well.

You can also search for recalls on the FDA’s website. The FDA maintains a database of products that are subject to both active and terminated recalls. The FDA also issues press releases about major product recalls, and it maintains category-specific recall databases for the following types of FDA-regulated products:

• FDA Animal and Veterinary Product Recalls
• FDA Biologics Recalls
• FDA Cosmetics Recalls
• FDA Drug Recalls
• FDA Medical Device Recalls

While there are various places to find information about FDA recalls, it is important to keep in mind that not all unsafe products are subject to recalls. As a result, the fact that a product is not currently subject to an active recall does not mean that the product is safe. Many mass tort lawsuits involve unrecalled products—and these lawsuits frequently result in substantial settlements for consumers, patients and their families.

What to Do if You (or a Loved One) Has Been Harmed By an Unsafe Product

With all of this in mind, what should you do if you (or a loved one) has been harmed by an unsafe product? While you can check to see if the product is subject to a recall, this should not determine whether you speak with a lawyer. As we just discussed, many unsafe product lawsuits involve unrecalled products—including many of the mass tort lawsuits that are currently pending in courts across the country.

Any time you are dealing with a product-related injury, your first priority should be to obtain any and all necessary medical care. Your next priority should be to consult with an unsafe product lawyer about your legal rights. The costs of product-related injuries can be substantial, and victims and their families will be entitled to financial compensation in many cases. This includes not only compensation for medical bills and other out-of-pocket costs, but for lost income, pain and suffering, and other financial and non-financial losses as well.

Request a Free Consultation with an Unsafe Product Lawyer at Searcy Denney

Do you need to know more about your legal rights after a product-related injury? At Searcy Denney, we represent individuals and families in cases involving all types of unsafe products. To speak with an experienced unsafe product lawyer about your legal rights in confidence, please call 800-780-8607 or request a free consultation online today.