Medical device recalls hit nearly two-year high
August 22, 2012
by Brendon Nafziger
, DOTmed News Associate Editor
Nearly 123 million medical devices, such as ultrasound gels and hip implants, were hit with recalls in the last quarter, making for a nearly two-year high, according to a company that tracks food, drug, device, and children's product recalls.
While the number of device recalls dropped since the previous quarter, the number of actual units affected passed the 100 million mark for the first time since the third quarter of 2010, according to a quarterly index on recalls published by ExpertRecall, a subsidiary of medical waste management giant Stericycle.
According to the index, Food and Drug Administration enforcement reports from Q2 2012 found 242 device recalls, down 13 percent from the 277 in the first quarter, but up 4 percent from the same period last year.
Around 123.5 million units were affected, however, a nearly 50 percent increase on the 82 million units slapped with recalls in the previous quarter. The number of recalled units this quarter is also nearly 8 times bigger than the 16 million or so units recalled in the second quarter of 2011.
However, fewer than 7 percent of recalls this quarter were deemed Class I, meaning the devices carried a risk of serious injury or death, and these recalls involved fewer than 1 percent of all recalled units in the quarter, according to ExpertRecall. Still, about 142 companies were hit with at least one device recall.
The group also noted 69 pharmaceutical recalls in the last quarter, affecting 12 million units of prescription drugs.
ExpertRecall said it compiles the data on recalls using FDA's weekly enforcement reports and press releases posted to its website.