Dive Brief:

• The number of medical devices recalled from the U.S. in the fourth quarter of 2018 jumped by more than 400%, according to regulated waste disposal and compliance company Stericycle.

• The quarter-on-quarter leap in recalled units resulted in 161 million products being pulled from the market, making last year's fourth quarter the second busiest three-month period since at least 2004.

• For the eleventh quarter in succession, software was the top cause of recalls, accounting for almost twice as many withdrawals as any other factor.

Dive Insight:

The sharp rise in the number of units recalled in the fourth quarter was underpinned by two driving factors. Firstly, the third quarter saw fewer units recalled than any time since the start of 2017, meaning the huge proportional increase in the fourth quarter was coming off a low base.

Secondly, some of the fourth quarter recalls affected far more units than is typical. In the third quarter, the average recall affected around 100,000 units. In the fourth quarter, FDA flagged a BD recall that affected almost 30 million Vacutainer Urine Collection Cups. BD took the action after learning its cups may contribute to a slight elevation in red blood cell counts.

BD’s outsized recall drove the average number of units involved in each action up to 575,000. Only one quarter since 2006 has seen a higher number of units per recall.

The other standout fact in the dataset is that five companies reported ten or more recalls in the quarter. That has only happened twice in recent years, specifically in 2013 and 2016.

In other regards, the quarter was in line with historical trends. The number of recalls dipped 1% from the third quarter to come in at 280. The number of recalls has fluctuated around 300 in most quarters over the past two years.

The causes of the recalls were familiar, too. Once again, software was behind more recalls than any other factor. As in the third quarter, mislabeling and quality issues were the second and third biggest causes of recalls but they trailed far behind software. While software accounted for almost 30% of recalls, mislabeling was implicated in just 15% of events.

The data cover the last completed quarter before FDA finalized its recall guidance, which last week offered protocol recommendations to companies and outlined how the agency will try to better communicate warnings to the public.