News Feature | September 10, 2014

Medical Devices Experience Fewest Recalls Since 2012

By Nick Otto


The medical device industry saw its lowest number of medical device recalls since 2012, according to new research from Stericycle, an 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 report. For the report, the company used data that it compiled quarterly using information from several government agencies, including the FDA.

According to the report, 28 percent of the companies involved in recalls this past quarter 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 timeframe.

Additionally, the report adds, more than half of the recalls — 57 percent — occurred within the U.S. 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 quarter 1 to quarter 2, 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 says.

“Our Q2 Recall Index underscores that even when recall rates remain relatively flat, the challenges of global recall response are still imminent,” said Mike Rozembajgier, VP of Stericycle, 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.

A report 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.