161 million medical device units recalled in Q4 2018

The number of medical device units recalled in the U.S. during the fourth quarter of 2018 skyrocketed by 449% to 161 million from the same quarter a year ago, according to a report by Stericycle Expert Solutions. Those figures made it the second highest quarter for medtech units recalled since at least 2004.

The actual number of medical device recalls fell by 1%, lower than the last three quarters’ figures.

At 73.5%, machine failure remained the top cause of recalls based on units for the second quarter in a row, while software — at 28.2% — led the way based on numbers of recalls for the 11th consecutive quarter, the report says.

Five companies reported 10 or more recalls in Q4 2018, making this the highest number since Q3 2016 and the second highest since Q3 2013. There were 79 software-related recalls, which far surpassed all other causes, including mislabeling (43 recalls), quality issues (36 recalls), and sterility problems (27 recalls).

The Stericycle Recall Index covers recalls in the food, pharmaceutical, automotive, medical device, and consumer product industries. The full Q4 2018 Recall Index is available here.