Medical device sector sees highest number of quarterly recalls since 2005, report finds

Software issues constituted the No. 1 reason for U.S. medical device recalls for the eighth consecutive quarter, according to a recent analysis of 2018 first-quarter recall data.

Each quarter, product recall management company Stericycle Expert Solutions releases a "recall index" detailing the frequency and causes of U.S. product recalls in the food, pharmaceutical, automotive, medical device and consumer product industries.

To compile its report on the first quarter of 2018, Stericycle Expert Solutions analyzed data from the Consumer Product Safety Commission, the FDA, the Food Safety and Inspection Service of the U.S. Department of Agriculture and the National Highway Traffic Safety Administration.

The management firm found 343 recalls took place in the medical device sector during the first quarter of 2018, representing the largest number of medical device recalls during a single quarter since 2005. The average recall size was 607,512, compared to the average recall size of 245,862 during the fourth quarter of 2017.

For the eighth consecutive quarter, the plurality of medical device recalls — 22.7 percent in the first quarter — were caused by software issues. Other top causes for medical device recalls included mislabeling issues (21.3 percent) and quality issues (13.4 percent).

To access Stericycle Expert Solutions' report, click here.

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