Serious medical device recalls nearly doubled in Q2


medical device recalls FDAMedical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions.

Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such a host of problems including failure to establish durability, approving products before they were ready, and poor quality of components.

There was also a noticeable uptick versus the previous quarter in pharmaceutical and food recalls that FDA labeled as Class I, according to the Stericycle report.

“Class I is the most critical type of recall, so to see increases across multiple industries where serious adverse consequences or death can occur is certainly concerning,” Michael Good, VP of marketing and sales at Stericycle ExpertSolutions, said in a news release.

Medical device recalls overall were down 3%, to 275 – making this year’s second quarter the lowest quarter for the number of device recalls over the past year. Recalled units, however, were up more than sevenfold in number – a 628% increase to nearly 67.6 million that made the second quarter higher than 15 of the last 18 quarters for the number of recalled units.

The average number of medical device units involved in Class I recalls is 876,076 per quarter so far in 2017, nearly triple the 310,158 average in 2016. The average was 276,233 in 2015.

Here are some of the notable FDA Class I recalls from Q2 2017:

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Associate editor Fink Densford contributed to this story.

Hear from top executives at Abbott, Google, Boston Scientific, Medtronic and more at DeviceTalks Minnesota, June 4–5 in St. Paul.


  1. William K. says:

    Providing the required level of quality is never simple and easy, and so it is natural that there will be failures. Of course not all regard the quality efforts as a cost reduction operation. But given the cost and liability issues associated with the cause for recalls, maintaining adequate quality is indeed a means of reducing expenses. AND it is a good sales tool, being able to state that ” we never have been recalled.”

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