Medical device recalls have increased dramatically in the past 10 years. A detailed report provided by the Food and Drug Administration (FDA) indicated that there was a 97 percent increase in the number of medical devices recalled annually from fiscal year 2003 to fiscal year 2012.
The FDA attributes the increase in recalls to enhanced awareness by medical device firms, especially those firms that were cited repeatedly for violations of safety rules and standards. Efforts by the Center for Devices and Radiological Health (CDRH) to improve device safety were also listed as a reason for the higher recall numbers.
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