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Product Liability

FDA Reports Rise in Medical Device Recalls

A report released on Friday from the U.S. Food and Drug Administration (FDA) shows that the number of medical device recalls has increased by 97 percent. The Center for Devices and Radiological Health (CRDC) is the group in charge of issuing medical device recalls and had a primary goal of lowering the amount of time it took to alert the public when a problem occurred.

While the information shows that actual recalls increased from 876 in 2010 to 1190 in 2012, the group was successful in its objective to give the public ample notice time, lowering the number of days a product was on the market by 56 percent.

The FDA reports that the most common reasons a device gets recalled is because design, software, non-conforming material, or component issues. It also says, “If industry and CDRH can address these problems jointly, we may be able to prevent as many as 400 recalls each year.”

As a conclusion, the FDA states that they believe the rise in recalls is actually a result of increased awareness by all involved parties. They estimate that these numbers will begin to reduce in upcoming years because the manufacturers are gaining useful knowledge and tools to improve device performance.

The FDA has also created a page that keeps up to date on medical device recalls. You can sign up at that site to receive email notifications when they issue new recalls or find contact information if you have more questions. Click here to view that page.

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