As stated before there are many reasons for a recall to occur. From personal experience I do not think it is the FDAs fault most of the time. The only reason it would be is a lack of auditing a certain company. Every couple years or so the FDA usually performs audits of medical device manufacturers and ensures they are following all the important regulations and engaging in Good Practices. Sometimes companies are left alone for maybe a decade though and may not be following procedures accurately which could result in product failures. It would be a major issue to perform manufacturing steps which have not been validated properly and deviate from what the FDA approved initially as suitable for consumers. If the manufacturer does this either on purpose or unknowingly, it still seems like it is negligence on the companies side, not the FDA. The FDA cannot vouch for processes that are not disclosed to them. Another example of a recall being the manufacturers fault is not assuring the quality of incoming parts from vendors. I know of a time when a supplier switched up the material on a certain tubing component and did not tell the manufacturer about it. This change in material resulted in tiny holes forming in the tubing later in the assembly process, causing failure of products. The medical device manufacturer needs to be very thorough since it is ultimately them who will be sued by adversely affected customers, not the supplier of the faulty part.