Medical Device Recalls Down Nearly 10%
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.
Related Articles
-
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
-
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap."
-
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
-
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers…
