According to a new report from the Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), the annual number of medical device recalls increased by 97% between fiscal years 2003 and 2012, to 1,190. The most frequent causes for recalls are related to device design, software, and non-conforming material or component issues. The number of Class I recalls went from 7 in FY 2003 to 57 in FY 2012, while Class II recalls rose from 460 to 1,043. The report states that the increase is due to a greater focus and attention on improving product quality in certain areas, including radiology devices, ventilators, infusion pumps and external defibrillators.
The report can be viewed at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM388442.pdf.