Medical device manufacturers initiated a record 360 recall events in the second quarter of 2018, beating out the previous record of 343 product recalls recorded in Q1. That's an increase of 17 events, or 5%, from the prior quarter, consulting firm Stericycle said in its most recent recalls index. Q2's 360 events also represents the most corrections and removals by device-makers in any quarter since at least 2005, when Stericycle began tracking device recalls by gathering data from FDA Enforcement Reports. On a somewhat brighter note, 42.2 million device units were recalled in Q2, down 80% from Q1, when firms recalled a whopping 208.4 million. Meanwhile, it's the third quarter in a row that manufacturers had troubles with software, mislabeling and quality; they were the top 3 causes of recall events again in Q2 2018.
From the editors of The Gray Sheet
