Software issues drive medical device recalls for 11th straight quarter, report finds

Software issues continued to drive medical device recalls during the fourth quarter of 2018, according to a recent analysis of U.S. recall data.

Each quarter, product recall management company Stericycle Expert Solutions releases a "recall index" that details 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 fourth quarter of 2018, Stericycle 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 firm identified 280 recalls from businesses in the medical device sector during the fourth quarter of 2018, down 1 percent from 284 recalls reported during the third quarter. The average recall size was 575,449, compared to last quarter's 103,375.

Recalled units rose 449 percent to 161 million, marking the second-highest quarter for recalled units in more than a decade.

For the 11th consecutive quarter, the plurality of medical device recalls — 28.2 percent — were caused by software issues. Other top causes for medical device recalls included mislabeling issues (15.4 percent) and quality issues (12.9 percent).

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