Medical Device Recalls Rise 27 Percent in Fourth Quarter

April 17, 2015

The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows.

Overall, 23.8 million devices were affected by recall actions during the quarter, up 27 percent from the third period. But the number of actual recalls for the fourth quarter dropped 26 percent to 220.

Agency-wide, there were 398 recalls during the quarter, which was the smallest number since Stericycle began tracking data in 2012. Devices showed the highest rate of international recalls among all product categories tracked by Stericycle, with 60 percent of FDA actions affecting at least one country outside the U.S. These included recalls in Bahrain, Brunei, Cuba, Fiji and Malta that posed extra challenges because of a lack of existing infrastructure such as local facilities or on-site representatives, Stericycle says.

One devicemaker saw 19 separate recall actions during the quarter, while another 36 experienced two or more recalls. Packaging and labeling issues were the most common cause for recalls, Stericycle says. The group predicts that recall response in future years will be eased by implementation of unique device identifiers.

The report was generated by analyzing FDA enforcement reports and product recall announcements.

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