Device Recalls Reach New High In 2006 As FDA Works On Postmarket

摘要

Although the medical device industry chalked up an all time high number of recalls in 2006 - driven in part byconfmued problems with infusion pumps and defibrillators - the number of Class I recalls actually fell. The total number of recalls in calendar year 2006 was up 5 percent over 2005, to 616 from 589 - the highest number of recalls iogged during a full calendar year since FDA's correction and removals regulation was enacted in 1997. The previous record was 612, reached in 2004 (see complete list of 2006 recalls, p. 10).