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Medical Device Recalls Hit Two-Year High

According a recent article on, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company tasked with tracking food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

ExpertRecall pointed out that the number of device recalls is actually down slightly from the first quarter. However, the number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. An analysis of FDA enforcement reports found that the second quarter of 2012 saw some 242 medical device recalls, a drop of 13% from the 277 recalls seen in the first quarter of this year. Though there was a drop, the most recent numbers still represent an increase of 4% from the same time last year.

The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Though the gap may seem larger, stepping back in time reveals an even difference. In the second quarter of 2011, only 16 million devices were recalled, about 1/8 as many as last quarter.

Though good news was hard to find in the report, one indication showed some promise. Less than 7% of the recalls announced last quarter were Class I, meaning that the device carried a risk of serious injury or death. Moreover, these serious recalls accounted for less than 1% of the total units recalled in the quarter, thus affecting only a small number of patients.

It wasn’t just medical devices that saw millions of recalls last quarter, the group revealed that there were 69 pharmaceutical recalls in the second quarter of 2012. These 69 recalls amounted to a total of 12 million units of prescription drugs.

Companies affected by the recent recalls include Coviden PLC, which recently announced a voluntary recall of some DGPHP RFA high-power single use grounding pads. It also announced a voluntary global recall of some adult tracheostomy tubes.

CareFusion Corporation launched a recall earlier this summer of its EnVe ventilator due to potential risks that the device could compromise patient ventilation. The company also announced a voluntary recall of its AirLife Infant Breathing Circuit.

Abbott Laboratories recalled some Architect Toco IGG Reagent kits while General Electric’s medical systems unit recalled X-ray machines due to faulty wheels. Perhaps most uncomfortable of all, Johnson & Johnson announced just this week that they would be recalling certain hemorrhoidal circular staplers due to the potential risks of a misfire.

If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:Medical device recalls hit nearly two-year high,” by Brendon Nafziger, published at

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