5 Medtech Firms with the Most Recalls

May 29, 2014

5 Slides

5 Medtech Firms with the Most Recalls

Updated August 26, 2015

Medtronic now rivals Johnson & Johnson as the largest medical device company in the world, thanks to its $48 billion acquisition of Covidien. The merger, however, also brings a less desirable statistic: most Class I–level recalls since the start of 2013. It didn't help that FDA filed a consent decree earlier this year against the company, alleging that it had repeatedly failed to address manufacturing problems related to its Synchromed II implantable infusion pump.

It is worth noting that huge global companies such as Medtronic, J&J, and GE, with tens of billions of dollars a year in revenue and countless sizeable product portfolios, are more likely to rack up recalls than smaller firms. 

However, multiple recalls involving infusion systems and tracheal and bronchial tubes helped land two companies with less than $5 billion in annual revenue on the list.

Here’s a rundown of the five companies stuck with the most Class I designation announcements, along with the products involved and the dates the FDA announced the Class I: Read on to find out more. 

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Flickr image used under Creative Commons license

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerBrian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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