FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes

The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “sends a message to the FDA that maybe you do not have control over your recall,” CDRH Recall Branch Chief Ron Brown says.