Medical device recalls occur when a company learns that an issue with their device has resulted in a problem. When either the manufacturer or designer discovers or are made aware of the defective or malfunctioning medical product, it is then that it is recalled. A correction occurs to a product when the issue at point of sale is resolved. A removal occurs when the product is removed from the marketplace.
Recalls take place when a medical device is deemed defective by the Food and Drug Administration when either the product itself is defective and/or it potentially poses a potential high risk to those that use it. When a device is recalled, it does not necessarily mean that a user must discontinue its use. Sometimes the defect to the device needs to just be fixed by way of an adjustment, such as an implanted device like a artificial knee.
Generally, it is the company or manufacturer that recall medical devices, thus on a voluntary basis. This usually occurs as the result of the company learning the product is in violation of FDA law. However, the FDA does have the legal right to order a recall. This is in very rare instances when a company refuses to recall a device that can present major health problems or even death.
Medical recalls are classified respective to their risk. Class I, the most serious, includes products with a reasonable chance of causing significant injury or death. Class II includes those that have temporary implications for one's health. Class III products are not likely to cause death or serious injury. The FDA ends the recall once the product becomes compliant with the law and no longer presents any serious health issue or injury.
It is not uncommon that a lengthy track record of injuries or death alleged to have resulting from the use of a defective medical product has been established before being taken off the market. If you or someone you know has been seriously injured by using a recalled product, a product liability attorney can help you make sense of your rights to compensation for medical expenses as well as pain and suffering in your case.
Source: U.S. Food and Drug Administration, "What is a medical device recall?," Jan. 03, 2017