Product recalls plummeted across all industries during the country’s recent government shutdown – the first significant drop in seven years – according to the Stericycle Expert Solutions’ first quarter 2019 Recall Index. However, the uncharacteristically low numbers suggest there could be serious vulnerabilities in the country’s current recall policy as products that might have been removed from shelves were missed.
“While it’s usually good news for consumers when recall rates decline, the Q1 2019 numbers are misleading,” said Chris Harvey, Director of Recall Solutions at Stericycle Expert Solutions in a news release. “Fewer inspections mean more potentially dangerous products entered the market unnoticed during this period, which could also have an impact in the months ahead.”
The shutdown ended in late January, but agencies were busy catching up and normal operations didn’t resume until weeks later.
The announcement explained that the declines were largely due to reduced oversight after the government shutdown earlier this year, causing some inspections to either stop or operate on skeleton crews, limiting the number of checks the agencies could reasonably conduct.
“Having a recall plan in place could never be more important as we track the repercussions,” Harvey said.
There were 39 product recalls in Q1 – a 43.5 percent decrease – while recalled units decreased 67.3 percent to 1.8 million. Both of these totals are the lowest quarter since at least 1997, according to the report. Other findings specific to medical devices and pharmaceuticals include:
Medical device recalls decreased 41.4 percent to 164, which is the lowest since Q4 2017. Recalled units decreased 16.2 percent to just under 135 million devices. More significantly, there were more than one million Class I units recalled for the third consecutive quarter. Class I devices pose the greatest risk to the public.
Quality issues were the top cause of recalled units at 51.2 percent. This is the first time quality issues were the top cause since Q3 2016. The average medical device recall impacted 823,126 units, making it the highest quarter since 2006.
Pharmaceutical recalls decreased 7.8 percent to 94, and recalled units decreased 75.3 percent to just under 13 million – lower than six of the last nine quarters.
Failed specifications and deviations from current Good Manufacturing Practices (cGMPs) drove drug recall activity in Q1. For the 11th consecutive quarter, failed specifications were the top cause of pharmaceutical recalls, while cGMP deviation was the top cause for recalled units.
Some pharmaceutical companies experienced multiple recalls in Q1 2019. Four drug makers reported at least five recalls each in the quarter – the highest number since Q3 2013.
