Medical Device Recalls Spike in February
Industry news | 08 April, 2019 | CACLP
FDA has reported a total of 10 medical device recalls so far this year, of which seven were reported in February. Seven recalls in a single month is a lot, but not unheard of.
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.
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."
Other companies that have recalled medical devices this year include (in order from most recent): Physio-Control, ICU Medical, Medtronic (two separate recalls), Edwards Lifesciences, Smiths Medical, West Pharmaceutical Services, Terrific Care/Medex Supply, Draeger Medical.
Press contact