There were more than 650 medical device recalls in the 3rd and 4th quarters, an increase of 44% compared with the 1st half of 2016, according to the report. That equates to the 2nd highest number of recalls since 2000. A total of more than 180 million products were recalled in total, the third highest half-year on record since 2000 as well, according to the report.
Software problems were the most common cause of recalls across both quarters, while product mislabeling came in a close second. For number of units affected, quality issues and mislabeling were the 1st and 2nd most common reason for recalls, followed by parts problems and sterility issues.
Unlike in consumer electronics, lithium-ion battery safety issues were minimal for medical devices, according to the report, with a likely reason being a significant disparity in quality control between medical devices and consumer electronics. The report did warn that litium-ion battery issues could become more commonplace as use increases, however.
“Medical devices are saving lives and improving the quality of life for millions of patients. But as medical technology advances and becomes more complex, these innovations can be more prone to defects, and therefore, more vulnerable to recalls. The challenge for medical device companies is that, unlike other industries, there is no single dominant cause of recalls they can focus on improving. Defects and quality problems were all over the map, from misalignment to unbalanced pH levels to improper product transportation. We’ve witnessed recall activity fluctuate across industries in recent quarters, and companies never know when their product will be next. It is crucial for businesses of all types and sizes to update their recall plans and prepare in advance to avoid potential consequences with both regulators and customers,” ExpertSolutions commercial & client services VP Michael Good said in a press release.