A new report has found that the number of medical device recalls was up 30% in the second quarter from the first quarter of the year, even though the number of units involved in recalls globally fell dramatically by 50% in the same period.
The Stericycle ExpertRECALL report found that there were 411 medical device recalls worldwide involving 9.2 million units in the second quarter of the year that ended June 30. Most of the recalls - 407 - involved less than 500,000 units of prodcut. The largest number of separate recalls that affected a company was 17.
So, which company issued these 17 recalls? ExpertRECALL doesn't identify companies but an independent review of the relevant FDA Enforcement Reports between April and June found that Siemens Healthcare was the culprit. This FDA Enforcement report from the week of April 10 lists several of the company's recalls
But is 17 an unusually high number?
"While it does seem high, it is typical with what we have seen in past recalls (to give you some context, in the first quarter, one company issued 24 recalls, and two companies faced 15 events each)," said Mike Rozembajgier, Vice President of Recalls for Stericycle ExpertRECALL via email. "What it speaks to is the importance of establishing a strong recall plan in advance and fully documenting the supply and production process."
Here are a few more details from the report: