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Protecting The Disabled And Injured Since 1974

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Protecting The Disabled And Injured Since 1974

How does the FDA’s recall process work?

On Behalf of | Oct 25, 2021 | Hernia Mesh |

Like several other agencies, the United States Food & Drug Administration has a process for removing unsafe drugs and medical devices from the market after they have been approved.

This process is similar in many respects to the steps other federal consumer protection agencies take, but it has its own quirks and variances.

It is important to distinguish a recall from a market withdrawal of a product. While a medical device company may remove a product as part of a market withdrawal, doing so does not automatically mean the product is either safe or unsafe.

Because companies may use the term in a confusing fashion, it is also important to remember that a voluntary recall is not an example of a medical device manufacturer being especially altruistic or proactive about safety.

A voluntary recall is what a manufacturer is allowed to do to remove legally unsafe products from the market before the FDA forces the manufacturer to do so through legal action.

The classification of a recall depends on how hazardous a product is. A Class I recall suggests that, after further study, the FDA believes the product could cause serious and permanent health impacts.

A Class II recall applies when a product potentially causes fixable medical problems or, albeit rarely, could in a handful of cases cause a serious and permanent condition. No one should think of a Class II recall as a minor affair.

A recall is not designed to collect compensation for victims

Several hernia mesh products have been recalled in recent years for a number of serious safety concerns.

While this is certainly not a bad thing, it is important for Birmingham residents to remember that recalls are designed to make sure a manufacturer removes its unsafe products from the market at its expense.  Recalls are not designed to get compensation to victims of dangerous products.

An Alabama resident who has been injured by a hernia mesh product may have to file an appropriate legal action in order to cover their losses.