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The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.
There was a dramatic increase in the number of high-risk class I medical device recalls in the second quarter of 2017. There were 15 class I recall events logged with US FDA from April through June, up 88% from the first quarter of the year, when only eight were posted, according to consulting firm Stericycle, which gathered its recalls data from FDA Enforcement Reports. Overall, recalls fell 3% in Q2 '17, to 275 (compared to Q1's 284). Meanwhile, the number of recalled device units increased by a massive 628%, climbing to nearly 67.6 million units in Q2 '17, from 9.2 million in Q1. For a snapshot of Q2 results, see the infographic of Stericycle data below.
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