What is a Medical Device Recall?

Medical Devices cover a broad range of equipment, instruments, and implants used by health care providers aimed to improve patients' health and treatment outcomes. The Food and Drug Administration, or more commonly known as the FDA, determines if a medical device is safe to be used on patients. The FDA determines the safety of a device based the information provided by the device manufacturer. Even after the FDA has approved a medical device, however, the device can be found defective causing serious pain, injury, and sometimes even death. The manufacturer of the device is responsible to ensure the safety of the device and required to report any defects or potential risks. The device will be pulled out of the market and the FDA will then regulate the device recall.



Does this Happen Often?

Though virtually thousands of Medical Devices are approved through the FDA, there are a considerable number of recalls each year. In 2011 alone, 41 devices were recalled because there was a serious risk of injury or death. It has been noted that the number of device recalls has been on the rise in the last few years, either from the companies that released them or from regulatory agencies like the FDA.



What Should You Do if Harmed by a Medical Device or Dangerous Drug?

Know that you have rights to protect yourself from defective devices. If you have suffered an injury or are experiencing abnormal side effects from a medical device, or a prescription drug, you should first contact your physician immediately. You may be able to receive compensation for your suffering and medical bills. Device manufacturers are responsible for the liability whether or not the product has been recalled. Contact a product liability attorney that specializes in these cases to see if you may be entitled to compensation.