A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inability to assure sterility of the product, which poses an increased risk of infection to the end user.
For this type of recall (product sterility), I do not feel as though the FDA is responsible. It is the responsibility of the manufacture to demonstrate that the medical devices they are selling is in fact sterile. Although the manufacture needed to provide evidence of product sterility during the FDA 510(k) submission of the product, this sterility issue could be due to instances which were not considered by manufacture which lead to the possibility of having a non-sterile product.