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Medical Device Recalls Spike Again - Updated

FDA recalls spiked again in July. Here's how the number of 2019 recalls (so far) compares with previous years.

FDA has reported a total of 29 medical device recalls so far this year, of which seven were reported in July. As of this time last year, the agency had only reported 14 medical device recalls, so device recalls do appear to be on the rise in the United States.

Last year there were a total of 32 medical device recalls, according to FDA's database, with seven recalls reported during November. There were also 32 medical device recalls reported in 2017, nine of which were reported during May. In 2016, there were a total of 39 medical device recalls, with six recalls reported during January that year. See the chart below for a complete month-by-month breakdown of recalls in the medical device sector from 2016 through 2019 (as of July 19).

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  • FDA medical device recalls
    Data Source: FDA
Image Credit: 
Data Source: FDA

FDA recently said it is taking new steps to strengthen and modernize the process for issuing a public warning about a voluntary recall and for notification of recalls.

"Most companies collaborate with the FDA to rapidly initiate voluntary recalls and work with their supply chain partners to remove the product from shelves to prevent further distribution," the agency noted. "And in general, a recall occurs quickly when the problem is discovered. However, there are situations where the FDA may need to provide safety advice to [the] marketplace to protect consumers."

Companies that have recalled medical devices this year include (in order from most recent): Becton Dickinson, Teleflex, GE Healthcare, Hamilton Medical, Edwards Lifesciences, Vyaire Medical, Cook Medical, Terumo Medical, Integra Lifesciences, Beckman Coulter Lifesciences, Ethicon, Alpha Omega Engineering, Brainlab, O-Two Medical Technologies, RVO 2.0, Physio-Control, Medtronic, Smiths Medical, West Pharmaceutical Services, Terrific Care/Medex Supply, Draeger Medical.

For details about 2019 medical device recalls, click here. For 2018 recalls, click here. For 2017 recalls, click here.

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