Register to attend the Medical Device Recalls conference, May 14–15, 2018 in Washington, DC. Or attend virtually. Learn moreSoftware, mislabeling, quality and manufacturing defects were among the top reasons for recalls in the fourth quarter of last year. Stericycle released its Recall Index for Q4 2017, noting that device recalls declined 9% to 152 recalls, which is the lowest quarter since the fourth quarter of 2011. Although the average size of a recall was 245,862, which was much lower than Q3’s 407,256 figure, the recall size was higher than 16 of the last 20 quarters.
For the seventh consecutive quarter, software issues were responsible for the most recalls (25.7%), followed by mislabeling issues (23.7%), quality issues (16.4%) and manufacturing defects (7.2%), which were responsible for nearly 41% of the recalled units.