Recalls are essentially inevitable no matter what. This could be soon after the product was given the FDA approval or many years after the product has already been in use. You could create a product such that it is considered “perfect” but there can always be something that goes wrong. No matter how much effort is put into the creation and testing of a product, there is always a possibility of some failure or defect in which the product may have to be recalled, either totally or some smaller quantity. Similarly, the FDA is simply giving the green light on a product moving forward. They are given all the information and they analyze everything to the best of their ability, but in the end, they are given what the company has provided for the product. In this sense, for a product that was recalled, the FDA cannot usually be blamed since in theory, everything they were given proved the product to be safe based on their own standards. Obviously, maybe with stricter restrictions or some more testing, the number of recalls could be reduced. However, at the end of the day, there will always be recalls no matter what change is implemented.
that's a really good question you brought up, but I guess it depends on what kind of product. FDA could recall a product if they hear or certain complaints form consumers. for example, if the product started not working as efficiently after 2-3 years but the company claims life-long functionality. in rare cases, some products might have bad side effects on patients and they wouldn't know of the complication instantly and FDA would have to recall the product to ensure the safety of the people.
This is an interesting topic and your experiences with a team making the recall or preparing to counter the recall are very informative. After reading some of the post, it seems that devices tend to always have some kind of defectiveness in longevity, but this is something that could possibly be listed under the limitations of the device or range for failure expectancy; therefore making it something expected. Now, if the device fails at an earlier point or has a different effect than those stated by the company, then the recall should definitely be done.
I have some thoughts about maintaining and kind of verifying efficacy of the product. Why does the FDA not mandate intervals of retesting the products every couple of years after release. For example, in the laboratory setting, there are governing agencies like CAP and NYS that mandate the continuous testing of a specific tissue (blood, BM, etc.) for accuracy and specificity; this test is done every two years or so. Why can's the FDA mandate the same accuracy and specificity testing (in other forms) for devices, specially biologics. After all, there are only so many variables (different patients) that are encountered during the medical trial. I see how this could create a huge overload of work for the company and the FDA, but could it be something that can be done?
I was wondering that why are the recall either made by company or made my FDA are of items which have been in the market for at least 5-8 years after the launch in market. Why cant they be either verified at first with proper precaution and even if they come in the market why would they wait till the customer complains reached a certain point too react on to it. Can you list the reasons and ways this can be avoided
The simplest answer is MONEY. Companies love money and as long as it is agreeing with the regulations they won't do a recall. There are usually 2 reasons to do a recall. First, it might be forced from FDA which the company has no choice but to do a recall. Second, if there is a lawsuit and only if they cannot buy out the one who created the lawsuit. It is mostly the profits if paying out the one who opened the lawsuit is more profitable than they will go with that root. If the lawsuit turns out to be bad for the company that the company will do recall saying I did what I need to do and here is collateral for your damages etc.
