Recalls of faulty medical devices nearly double from 2003 to 2012, but the FDA says the increase is due to growing awareness of what types of problems merit action.
The annual number of medtech recalls nearly doubled from 2003 to 2012, but FDA regulators are calling the skyrocketing figures a win.
There were 604 total recalls in 2003, compared with 1,190 in 2012. The number of Class I recalls, tied to product defects that the FDA says pose a risk of "serious adverse health consequences or death," increased more than 8-fold, from 7 in 2003 to 57 in 2012.
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