Basically recalling any devices means that a company learnt that it has a device or a product that is violating FDA Laws. So in this case it does two things recalls and gives notification to the FDA. Recalls are also classifies into 3 categories Class 1 that causes severe health hazard, Class 2 causes reversible or temporary hazard, Class 3 does not cause health hazard.

According to me the simplest thing is to label the products with warnings, and instructions. Before launching any product in market we should do proper critical assessment for all kinds of risks.