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# Recalled Medical Device/Drug Unit Numbers Down: Stericycle
- URL: https://www.fdaweb.com/recalled-medical-device-drug-unit-numbers-down-stericycle/
- Published: 2016-05-19T12:00:00.000Z
- Updated: 2026-09-14T21:04:04.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5135713

The 2016 first quarter Stericycle Recall Index [says](http://www.stericycleexpertsolutions.com/wp-content/uploads/2016/05/STCExpertSOLUTIONS-RecallIndex-US-Q12016-FINAL.pdf?ref=fdaweb.com) that the number of recalled drug and medical device units dropped significantly in the quarter. The analysis shows that while the number of drug recalls remained consistent with the historical average, the number of units affected dropped to the second lowest quarter in the last decade. For medical devices, both recalled units and the number of recalls declined to the lowest level since 2013\. Those two medical device measures dropped roughly 30% from the quarterly average over the last two years, the report says.

More than half of recalled drug units were Class 3, a change from recent years in which more hazardous Class 2 recalls were typically the highest percentage. The average drug recall size in the first quarter of this year was 55,000 units, said to be a major decline from the historical average of 150,000\. The average number of units per recall has dropped from 345,291 in 2014 to 55,169 in this year’s first quarter. And in a continued downward trend, only five companies experienced more than one recall in the quarter.

Stericycle says that 77% of all drug recalls were nationwide and 43.6% of all recalled units were the result of a single recall, which totaled 1.4 million units due to mislabeling. Some 53% of all recalled units were due to mislabeling.

For medical devices, 75% of the largest recalls in the quarter were due to machine failure, making that the top cause of recalled units. Overall, 62.6% of the quarter’s recalls were due to machine failure, followed by 10.2% due to a quality issue, 9.9% sterility, 7.1% calibration error, and 3.9% software. The report says that less risky Class 2 situations made up 98% of the quarter’s recalls, but still declined from the 2015 quarterly average. In the quarter, no medical device company experienced more than 10 recalls, down from the historical trend of 20 or more in a quarter. The two largest recalls made up more than half of the recalled units, both due to machine failure. Some 58% of all medical device recalls were nationwide.