What is a Medical Device Recall Or Drug Recall?
When you hear about a medical device recall or drug recall, what exactly does that mean? Are you at risk? What can you do to understand how this may affect you? This series of posts will walk you through the basics of understanding medical device recalls and drug recalls and what you can do to assess the risks. The Food and Drug Administration (FDA) is the governmental entity that regulates the medical device and pharmaceutical industry, but the FDA isn’t usually the party that initiates device recalls or drug recalls. In most cases, the medical device or drug manufacturer discovers a potential problem and initiates a recall, reporting such action to the FDA. Manufacturers, in most cases, understand the risks to public health (as well as risks to their business) and tend to be proactive in addressing problems. Failure to take such actions can result in far greater consequences to a company; therefore most companies do behave responsibly once problems are known. When a company decides t