CDRH Report: Increase in Medical Device Recalls Attributed to Improvement Efforts

April 4, 2014 | Strategic Insights for Ambulatory Care


The annual number of medical device recalls increased by 97% between fiscal years 2003 and 2012, to 1,190, states a report from the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). The agency attributes the increase to both enhanced awareness by device firms, including those that were cited for reporting violations, and specific CDRH efforts to improve medical device safety. According to the report, the most frequent causes for recalls are related to device design, software, and nonconforming material or component issues. It estimates that if these problems are addressed jointly by CDRH and the industry, as many as 400 recalls could be prevented each year.

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