I recently worked on a product that was recalled voluntarily by our company. I want to make the distinction between a voluntary recall and an FDA mandated recall. A voluntary recall is when a company’s post market surveillance of a product shows that there are recurring problems that they feel are a risk to the patient and therefore they voluntarily recall the product so it does not cause additional harm. An FDA mandated recall is usually more severe, because this means that the product issues have caught the attention of the FDA and that they have deemed it unsafe. dag556 made a very good point that the device manufacturer is ultimately responsible for the product, and the FDA approval is just a check to ensure that the manufacturer has gone through all necessary steps in the development of its product. However, no matter how robust a design is, there is always the potential for unforseeable risks that were not visible to the manufacturer or the FDA at the time of approval.