Device Industry Posts Fewest Recalls in Two Years

The medical device industry experienced its lowest number of medical device recalls since 2012, according to new research from Stericycle, a medtech industry recall consultancy.

In total, 275 recalls occurred, including devices from 148 different companies—the lowest number since the second quarter of 2012, according to the 15-page report. The company based its report on data it compiled quarterly using information from several government agencies, including the U.S. Food and Drug Administration (FDA).

According to the report, 28 percent of the companies involved in recalls in the second quarter (ended June 30) had two or more products recalled, and 7 percent of the companies involved had five or more recalls. Stericycle identified one company that accounted for 18 percent of the total volume of recall activity alone, comprising 26 different recalls throughout the reported time frame.

Additionally, the report adds, more than half of the recalls—57 percent—occurred within the United States and just one other country. And, although the overall number of units recalled decreased 47 percent from 29.4 million units to 15.5 million, Stericycle still reported an uptick in recall volume. From the first to the second quarter, an 82 percent increase was noted in the volume of recalled units, the report states.

The FDA reported 495 total recalls, which included pharmaceuticals and food products, showing an overall decrease of 10 percent from the previous quarter, the report claims.

“Our Q2 Recall Index underscores that even when recall rates remain relatively flat, the challenges of global recall response are still imminent,” Mike Rozembajgier, vice president of Stericycle, said in a statement. “For example, many pharmaceutical manufacturers experienced multiple events that varied significantly in size and scope. This broad scale highlights the importance of flexibility and scalability to efficiently tailor recall response based upon the circumstances at hand.”

Contrasting numbers were released a year ago, with the same report noting a five-quarter high in medical device recalls, which points to an increase in global frequency.

An analysis earlier this year from the FDA also noted that device recalls over the past decade has more than doubled, with software-related recalls accounting for the most common type of device recall.