ABSTRACT

According to the ExpertRECALL Index, a report that aggregates and tracks cumulative recall data from the Consumer Product Safety Commission and the U.S. Food and Drug Administration (FDA), medical device recalls documented in the FDA’s first-quarter enforcement reports in 2012 affected

nearly 82 million units, a 5-quarter high [1]. Products impacted by the increase included alcohol prep pads, catheters, needles, latex gloves, and other medical device products.