Good news for the medical device industry: After two record-setting quarters, the number of recalled products fell to 284 in the third quarter of 2018 from a high of 360 recorded in Q2. That marks a decrease of 76 events, or 21%, from the prior quarter, consulting firm Stericycle said in its most recent recalls index. The 284 recalls initiated in Q3 is also 17% lower than Q1's 343 events, according to Stericycle, which tracks device recalls by gathering data from FDA Enforcement Reports. Also down in the third quarter was the number of recalled device units, which dropped to 29.4 million from Q2's 42.2 million – a decrease of 31%. And for the 10th quarter in a row, device-makers blamed software issues as the top cause of recalls, trailed by mislabeling and quality.
From the editors of The Gray Sheet
