Recalls are a very interesting topic, nice post. Recalls are done, not by the company that designs and develops the product, but by the manufacturer or distributor. When these parties find that the medical device violates an FDA law (e.g. efficacy or failure to perform what it was designed for) they initiate a recall. How did this device slip through the Monitoring and Control processes, rigorous Verification and Validation, and FDA inspection? This proves that the PM processes and Design Control though effective at ensuring quality products are not infallible. Then can they be improved to a point where recalls never happen? As the posts above have said, the recall identifies a change that needs to be made to the device, a ECO must be issued and the Planning process must be revisited. Then the company must ensure the FDA that the problem has been fixed and no more laws will be violated. This would require some very convincing Verification and Validation data. Once ensured the FDA will retract the recall.
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm