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Home » Report: Medical device recalls hit 3-year low in Q1

Report: Medical device recalls hit 3-year low in Q1

May 20, 2016 By Brad Perriello

Sterigenics medical device recall indexMedical device recalls fell to their lowest point since 2013 during the 1st quarter, according to a report from Stericycle‘s (NSDQ:SRCL) ExpertSolutions business.

Both the number of recalled units and the actual number of recalls hit 3-year lows, coming in at 30% below their 2-year quarterly averages, according to the report:

Medical device recalls Q1 2014 - Q1 2016

About 75% of the largest recalls during the quarter were related to machine failure, Stericycle ExpertSolutions said, noting that the 2 largest recalls were for machine failure and collectively accounted for more than half of the total number of recalled units.

All but 2% of the recalls during the 1st quarter involved Class II devices, the company said. Over all, 62.6% of Q1 recalls were for machine failure; 10.2% involved a quality issue; 9.9% were for sterility issues; 7.1% came due to calibration errors; and 3.9% were software-related, according to the report.

Filed Under: Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: stericycle

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