The year 2015 is off to a great start in the medical device industry, with medical device recalls falling to near-record lows in Q1. That’s according to a review of the Food and Drug Administration’s (FDA) data conducted by Regulatory Focus.
Reviewing the FDA’s data shows that while 968 separate device recall events took place in the fourth quarter of 2014, only 426 recalls took place in the first quarter of 2015. This figure marks the lowest recall total since Q1 of 2013 when 367 recall events took place.
So why the big change between Q4 of 2014 and Q1 of 2015?
According to the Regulatory Affairs Professional Society (RAPS) three large incidents involving more than 721 recalled devices took place in 2014, making recall numbers especially high. In one instance, 233 devices were recalled because of packaging flaws. Even though the supplier and customer were the same for each device, it still counted as 233 recalls. The first quarter of 2015 represents a shift away from these previous outliers and a lower, more positive recall number.
It’s also important to point out that the recall numbers show only the number of different models recalled, not the total number of devices recalled. Some recalls may affect 10 or fewer devices while others can affect thousands or even millions. Each case is treated as one recall incident. It’s also worth noting that the FDA’s entrance of a recall reflects the date the FDA classified the recall, not the date when the recall actually occurred.
After recalls peaked at the end of 2014, a recall reduction of more than 50 percent last quarter is a great way to start the New Year. History shows recall numbers have fluctuated in Q2, being both higher or lower than their Q1 counterparts in 2013 and 2014. As the industry moves forward, it would prefer the latter.