Report: Software issues continue to drive medical device recalls in Q4

Software issues constituted the No. 1 reason for U.S. medical device recalls for the seventh consecutive quarter, according to a recent analysis of 2017 fourth-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 fourth quarter of 2017, 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.

There were 152 recalls in the medical device sector during the fourth quarter, representing the lowest recall quarter in six years. The average recall size was 245,862, compared to the average recall size of 407,256 during the third quarter of 2017.

For the seventh consecutive quarter, the plurality of medical device recalls — 25.7 percent in the fourth quarter — were caused by software issues. Other top causes of medical device recalls were mislabeling issues (23.7 percent), quality issues (16.4 percent) and manufacturing defects (7.2 percent).

To access Stericycle Expert Solutions' report, click here.

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