Labeling, Software Problems Drive Majority of Q3 Device Recalls

Labeling and packaging errors and software problems accounted for more than 40 percent of medical device recalls during the 2014 third quarter, according to compliance company Stericycle.

“Among the software glitches were anomalies with calendar settings, discrepancies with digital images, and spontaneous rebooting resulting in unintended downtime,” the company says.

Stericycle, which produces a quarterly recall index, predicts that software errors will continue to drive device recalls going forward as the use of advanced technology increases. “As manufacturers invest in new technical innovations and integrate technology into existing product lines, it’s critical that they adapt recall planning accordingly,” the firm says.

The company forecasts a “cloudy outlook” for the device industry, thanks to recall volume and a variety of other factors. Device recalls hit 297 in the third quarter, up 8 percent from the previous quarter. Meanwhile, “geographically distributed events, technological advances and new regulatory requirements,” also contribute to a shaky landscape, the report says.

“Medical device manufacturers are grappling with these challenges while simultaneously seeking to capitalize on the industry’s growth potential, which some estimates put at $514 billion by 2020,” the report says.

As for the global impact of device recalls, the report notes that 57 percent of the industry’s third-quarter recalls affected at least one other country in addition to the U.S. “While looking specifically at overall FDA global recalls, the medical device sector has the highest percentage of global events,” Stericycle says.

And device recalls are increasingly affecting island nations, where most manufacturers lack a ground presence, creating logistical challenges for recall management and execution, the report says. Ongoing implementation of the unique device identifier system may help to ease recall management in such locales and more efficiently define a recall’s scope, Stericycle says.

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