The number of medical device recalls has increased 38 percent in the second quarter of 2016, according to findings from Stericycle ExpertSolutions.
While the first quarter of 2016 had a major plunge in recalls, this quarter’s jump is tied with the highest quarter of recalls since the third quarter of 2014.
Here are a few important stats regarding the increase in medical device recalls:
- 99 percent of recalled units were considered Class II, continuing a trend that began in Q1 2015.
- The top three causes based on recalls were software, mislabeling, and quality issues.
- Quality issues, out of specification, and sterility concerns made up 87.8 percent of recall reasons based on units.
- Forty-nine percent of medical device recalls were international, the lowest level since Q4 2013.
The top medical device recall causes were quality issue (39.7 percent), out of specification (26 percent), sterility issue (22.2 percent), mislabeling (4.3 percent), and manufacturing defect (3.7 percent), with 4.1 percent being for other various reasons.
Recalled medical device units were three times higher in the second quarter, but were still 30 percent lower than the quarterly average in 2015.