Q1 Recalls Snapshot: Recalled Units Skyrocket 457%; Largest Quarterly Number In 13 Years

More medical devices were recalled by manufacturers in the first quarter of 2018 than in any quarter since at least 2005, consulting firm Stericycle said in its most recent recalls index. There were 343 recall events initiated in Q1, a 126% increase over Q4 2017, when there were 152. Q1 2018 had the largest number of recall events in a given quarter since Stericycle began tracking medical device recalls 13 years ago. Moreover, the number of recalled device units also skyrocketed, from 37.4 million in Q4 '17 to 208.4 million in Q1 '18 – an increase of 457%. Stericycle, which gathered its recalls data from FDA Enforcement Reports, noted that the number of Q1 recalled units was more than all of 2017's recalled units combined (182.2 million). Troubles with software, mislabeling and quality were the top 3 causes of recall events in Q1 2018 – the same as in Q4 2017.

From the editors of The Gray Sheet