Medical device sector sees most quarterly recalls in over a decade

Jessica Kim Cohen -

The second quarter of 2018 saw the largest number of medical device recalls during a single quarter since at least 2005, according to a recent analysis of U.S. 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 second 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 firm identified 360 recalls in the medical device sector during the second quarter of 2018, up 5 percent from the first quarter.

Recalled units dropped 80 percent to 42.4 million, compared to last quarter's 208.4 million.

For the ninth consecutive quarter, the plurality of medical device recalls — 23 percent in the second quarter — were caused by software issues. Other top causes for medical device recalls included mislabeling issues (20 percent) and quality issues (16 percent).

To download Stericycle Expert Solutions' report, click here.

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