The volume of product recalls in the medical device category rose sharply in 2021 compared to the previous year – up 40% to 2,886. Quality issues were the most common reason listed for medical device recalls throughout the year, accounting for 21.8% (630) events. Software was the leading cause of product recalls in Q3 and Q4 and finished the year as the second most common reason for medical device recalls with 408, followed by sterility (275).
Germany was the top country for notifications, followed by Italy and France. In terms of country of origin for recalled medical devices, the same three countries topped the list. While there were no medical devices recalled in Europe that originated in the United States in the first half of 2021, there was a jump in the second half of the year to finish with 169 events.