Medical Device Recalls are either corrections or removals, depending on where the action is applied. The FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Despite the great care taken during the development of medical devices, errors can still occur. The important thing, therefore, is to establish proactive practices to determine ‘recall readiness’ after launching of a medical device product.