While medical device recalls in specific dropped 41.4% to 164, the lowest since the fourth quarter of 2017, the number of devices affected by the average recall was 823,126 units, the highest it has been since 2006. Total recalled units decreased 16.2% to just under 135 million devices, Stericycle said, down from 161 million during Q4 2018.
Quality issues were the top cause of recalled units at 51.2%, according to the report, marking the first time since the third quarter of 2016 in which quality issues were the most common.
Overall, product recalls across all industries declined, mostly due to a government shutdown which stopped or restricted many safety inspections normally performed through government agencies, according to the report.
The drop was the first in the U.S. since 2012, according to the report. Despite the government reopening at the end of January, several more weeks of delays followed as regulatory agencies ramped their inspections back up to normal levels, Stericycle reports.
“While it’s usually good news for consumers when recall rates decline, the Q1 2019 numbers are misleading. Fewer inspections mean more potentially dangerous products entered the market unnoticed during this period, which could also have an impact in the months ahead. Having a recall plan in place could never be more important as we track the repercussions,” recall solutions director Chris Harvey said in a prepared statement.
Pharmaceutical recalls dropped 7.8% to 94, with recalled units decreasing 75.3% to just under 13 million, lower than six of its last nine quarters. Failed specifications and deviations from current Good Manufacturing Practices drove pharma recalls during the quarter, and four drug makers reported at least five recalls in the quarter, the highest number since the third quarter of 2013.
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