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FDA - Recall Types

A product recall is a notice to the public and consumers that a product is unsafe. The U.S. Food and Drug Administration (FDA) and product manufacturers initiate recalls. Most recalls apply to consumer goods, but that isn't always true. For example, the FDA or manufacturers may recall a dangerous drug or defective medical device.

Recalls occur in one of two ways. The company may issue a voluntary recall of their products if they think they pose a danger to public health. Or the FDA ( can demand that manufacturers issue a recall.

In either case, the FDA monitors the recall process and consults with the company regarding the recall's effectiveness. It also determines whether products are safe enough to reenter the market.

This article discusses how FDA recalls work, the types of recalls, and what to do if you get hurt using a recalled product.

FDA Recall Procedures

The recall process begins when the FDA learns its regulated product may be dangerous to public health. There are several ways the FDA can find out about hazardous products. These include the following:

  • The manufacturer discovers a defect and contacts the FDA
  • The FDA receives reports of health problems stemming from a particular product
  • The Centers for Disease Control (CDC) notices a trending health problem related to an FDA-regulated product
  • FDA employees inspect the manufacturer's factory and determine that there is a likelihood that problems will arise

Once the FDA determines a recall is necessary, it works with the manufacturer to remove the product from stores, hospitals, and doctors' offices. Many times, this happens without any public notification.

The FDA only alerts the media in cases where the potential harm from the product is serious. But all product recalls are available on the FDA's website. You also can sign up for a newsletter about FDA recall information and get the safety alerts sent directly to you.

The FDA issues a public warning by listing the product and brand name. They also list the reason for the recall. For example, the FDA may report undeclared ingredients (like nuts) or specific bacteria detected (like salmonella).

The FDA also provides an FDA Enforcement Report, which determines the recall strategy. This may be market withdrawal or label correction.

What Is a Partial Recall?

Sometimes, the FDA only recalls specific batches of a product. If only one lot number contains damaged or defective products, the manufacturer doesn't have to recall all units.

When the FDA issues a partial recall, it will provide the manufacturer with instructions on identifying the defective units. For example, it may give the company a date range to check. Or it may provide the company with a list of specific lots with defective units.

Recall Classifications

The FDA splits its product recalls into classes: Class I, II, and III. The FDA categorizes products based on the potential for injury. Class I recalls are the most serious. This is for products that may seriously harm or kill a consumer. Class III includes products that may pose a risk to specific (but not all) consumers.

Descriptions of the classes are as follows:

  • Class I: Recalls for products that could cause severe injury or death
  • Class II: Recalls for products that might cause significant injury or temporary illness
  • Class III: Recalls for products that are unlikely to cause injury or illness but violate FDA regulations

When the FDA notifies the public of a recall, they will identify which class of recall the product falls into.

Class I Recalls

Class I recalls apply to products that pose a serious risk to consumers. Many of these recalls are for products that can (or have) caused death. Some vehicle recalls fall into this category. For example, a vehicle defect that causes the car to catch fire qualifies as a Class I recall.

Some dangerous drugs can also fall into this category. For instance, if the FDA learns a particular medication causes cancer, it will likely categorize it as a Class I recall.

Class II Recalls

Class II recalls involve products that can cause severe injury or temporary illness. This wouldn't apply to drugs that cause cancer. Nor would it apply to medical devices that cause serious bodily harm.

A prime example of a Class II recall would be a toy that presents a choking hazard to young children. While not all children who swallow a small component of a toy will choke and die, there is a risk that children will suffer serious injury.

Class III Recalls

Most FDA and manufacturer recalls fall into this category. In these cases, the product isn't likely to harm anybody. However, the item does violate FDA regulations. An example of this could be a product that doesn't include adequate warnings. A vehicle whose rear brake lights burn out too quickly could be a Class III recall.

What Should I Do if I Have a Recalled Product?

If you discover that the FDA recalls a product you own, don't panic. Go online and research the recall on the FDA's website. You can also find information on the manufacturer's website. Look for the reason for the recall. It's possible that the product only poses a danger to pregnant women, immunocompromised patients, or some other narrow segment of the population.

Call your doctor to determine whether you should keep taking the drug or need a new prescription if there is a drug recall.

If you determine the product may be dangerous, stop using it. If the product is non-perishable, like pills or cosmetics, keep the product in a safe place. Don't throw it out. Your personal injury lawyer may need it in preparation for your case.

What To Do After a Food Recall

It's common for the FDA to recall food products. You will often hear news stories on the FDA recalling lettuce or some other type of produce. There are also frequent recalls of meat and poultry.

If the FDA or a company recalls food, throw it out. It doesn't matter how much it costs; no food is worth keeping if it can harm you. Save your receipts and labels. You'll need them as evidence later.

Once you discard the food, employ food safety techniques to prevent other foodborne illnesses from spreading.

Throw out any utensils that came into contact with the recalled food. Thoroughly clean and disinfect countertops and other surfaces that touched the recalled food. Failing to do this can create a health hazard because it may cause cross-contamination.

Is a Recall Evidence of a Company's Liability?

Some manufacturers don't recall dangerous products because they don't want legal action filed against them. They fear consumers will sue them for damages if they recall a product.

While it may help to submit evidence of a recall, your product liability attorney must still prove your case. Just because a product is subject to a recall doesn't mean it's unsafe overall. You must demonstrate you suffered adverse health consequences to collect damages.

Your lawyer will consider the details of the recall, including which products were affected, the danger involved, and the degree of risk.

Remember that if a company issues a recall but you don't replace or repair it, it can hurt your case. The defendant will argue that you wouldn't have gotten hurt had you followed up on the recall.

Learn More About Product Recalls From an Attorney

If you're hurt while using a recalled product, you may have a cause of action against the manufacturer, distributor, retailer, or anyone in the distribution chain. Your attorney will demand compensation for your medical expenses, lost wages, and pain and suffering.

Contact a skilled product liability attorney in your area to learn whether you have a viable product liability claim.

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