FDA Recalls
Recalls of medical devices may be issued voluntarily by the maker of the suspect device or upon FDA mandate after the device is found to be defective. Fast-track FDA clearance rules coupled with aggressive marketing tactics on the part of the device manufacturers have contributed to some of the most recent device recalls. Other reasons for such sweeping action include design flaws and manufacturing defects. Limited FDA recalls which apply only to certain batches of a product are also common within the industry. Learn more about the devices recently removed from the U.S. market.
FDA Recalls
FDA Recalls
Medical device recalls are issued upon the analysis of a significant number of adverse events reported to the manufacturer and to the FDA. Some recalls are left to the discretion of the device maker while others are pursuant to federal order. In both cases, patients who have had the devices implanted may qualify for compensation through legal action.