When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don’t really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products can’t be prescribed to a specific group of consumers, it can be used by young and old, readers and non-readers, etc. So risks written on the labels must be very very low and highly infrequent. When it comes to surgical devices on the other hand, some of the risks written on the label can occur if instructions are not followed precisely. This is why surgeons prefer using the instruments they are skilled and well-versed at, they hate trying new products. So when they get into the surgery room, they use instruments they have practiced with for years, they don’t use new ones for which they need to read the label at the time of surgery.

So my point is that (as per my experience and knowledge) labels do well in informing their users about the risks. OTS products don’t really carry much risks and it is needed that are so, because of their broad range of users. Surgical instruments can carry major risks if not used properly, this is why the surgeons practice and get skilled in using it correctly before they use it on real patients.