There is a lot of confusion around recalls, the classification thereof and related information, especially when it comes to the recall of hernia mesh products. One of the best places to research this is of course on the US Food and Drug Administration (FDA) site. The governmental agency regulates these recalls and provides a wide range of information on this subject. However it can sometimes be difficult to locate the exact information you may be looking for, and therefore we have isolated this information and provided it here.
Types of Recalls
Hernia mesh falls within the medical devices category (see recalled hernia mesh products). The FDA provides that the majority of recalls are voluntary, however there are circumstances where the administration needs to intervene and in which case this is referred to as a mandatory recall. Closer analysis of the different types and processes of the “recall” provide different ‘names’ for what basically come across as being the same thing. It does appear that these do in fact provide some sort of respite to the manufacturer in avoiding potential penalties by the FDA.
The FDA provides a list of definitions, which we have added to our website here: Recall, Withdrawal Definitions