FDA Recalls

A prescription medication or medical device may be subject to recall if it is determined that the product is defective or may be causing harm to those using it. When a medical product is recalled, it is taken off the market. However, this is not an FDA action. Instead, the manufacturer of the product in question is responsible for initiating the recall. This occurs when the FDA receives post-marketing reports of adverse events linked to a medical product.

In the case of defective or harmful prescription medications, the FDA can recommend that the manufacturer remove the product from the market; however, the manufacturer is not obligated to do so. If a drug company chooses not to follow the recommendation, the only action the FDA can take is to file a lawsuit. Unfortunately, because of misplaced government priorities today, the FDA often lacks the resources to enforce recalls through the courts. Because of this, many harmful drugs continue to be sold and used for years.

The law does allow the FDA to force a company to recall a medical device or a bio-pharmaceutical product (such as a vaccine or blood product) if the product is determined to be harmful.

In either case, because of the profit-driven nature of the U.S. health care system, companies that manufacture health care products rarely initiate a recall on their own. Typically, this happens only after the FDA has called attention to the issue after learning about problems – either through the agency’s own adverse event reporting system (the Manufacturer and User Facility Device Experience database, or MAUDE) or from the Centers for Disease Control (CDC).

Occasionally, a company will discover problems as the result of post-marketing studies and may notify the FDA, but they do not often do this willingly because of the potential effect on revenue and profits.

Even when a problem with a health care product comes to the FDA’s attention, the agency is required to take a number of steps before recommending or requesting a recall. Once a dangerous or defective product has been identified, a scientific committee is formed for the purpose of review. The committee must consider:

1. what harm has already been caused by the product
2. co-morbidities or pre-existing conditions that may have contributed to the injury
3. the severity of the effects
4. how these may affect certain individuals or groups and to what degree
5. Immediate and long-term consequences

Once the product has been reviewed and the dangers have been evaluated, the FDA assigns it to one of three recall classifications:

1. Class 1: The most serious category, for products that may cause permanent injury or death
2. Class 2: For products with side effects that are temporary or reversible
3. Class 3: Medications and (less often) devices worn outside the body that pose little danger, but may malfunction or fail to perform properly

When a product is recalled, the FDA issues a notice on its website, informing the general public of the nature of the recall (Class 1, 2 or 3), the reason(s) for the recall, lot numbers, contact information for the manufacturer, and return procedures. News on recent recalls can be found at the FDA website under Enforcement Reports, which is updated regularly.

In some cases, the FDA and/or the manufacturer may issue a safety advisory, which may or may not lead to a recall. There are also instances in which a device or drug is simply taken off the market without a formal recall because of safety concerns, or (more frequently) due to poor sales. A recall may also be reversed or terminated if the manufacturer is able to address problems with the product in question.

Approximately 4,500 medical devices are subject to recall annually. A significant number of recalls since 2013 are due to software malfunctions, caused in large part by manufacturers who rush to get their products on the market before competitors. A comprehensive list of recalls can be accessed at the FDA website.