Why companies recall medical devices

Tennessee residents may want to learn more about medical device recalls. Medical device and pharmaceutical recalls occur when there exists an issue with a drug or device because it fails to comply with one or more rules established by the U.S. Food and Drug Administration. If a device poses a health risk or is defective, a company may recall the product to be returned or repaired. A medication recall is usually issued when it is discovered that a medication poses a particular health risk to consumers.

Recalls are issued with various instructions for correction or removal of defective, unsafe or malfunctioning products. The action required depends on the nature of the recall. Companies may recall products that have the potential to malfunction as a precautionary measure although it is unclear which individual products may be affected. Alternatively, when there is a clear risk associated with a product or medication, a recall may require that an implanted device be removed or that an individual cease use of the medication. In other cases, a recall may simply be issued to notify a customer and monitor their health for possible problems.

When a company who markets or manufactures a medical product discovers that it poses a risk, it issues a recall and notifies the FDA. If a company refuses or neglects to recall an unsafe product, the FDA can legally force the company to issue a recall. Although this legal right exists, the FDA has rarely had to exercise it.

Consumers in Tennessee who are injured as a result of a dangerous or defective product may have a number of legal remedies available. Manufacturers and distributors have a duty to provide safe products to consumers. Product liability laws are in place to protect individuals from injuries resulting from unsafe products and to provide relief for those affected by such products.

Source: U.S. Food and Drug Administration, “What is a Medical Device Recall?”, October 21, 2014