Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions.
Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such a host of problems including failure to establish durability, approving products before they were ready, and poor quality of components.
There was also a noticeable uptick versus the previous quarter in pharmaceutical and food recalls that FDA labeled as Class I, according to the Stericycle report.
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