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Reflections on Recalls: Five Years of the Stericycle Expert Solutions Recall Index

Q4 2017 Recall Index Reveals Zero Fines for Consumer Products, Continued Decreases in Medical Device Recalls, and Severity of Drug Recalls Continuing to Rise, Among Other Findings

Company Release - 2/6/2018 9:00 AM ET

INDIANAPOLIS, Feb. 6, 2018 /PRNewswire/ -- For five years the quarterly Recall Index from Stericycle Expert Solutions has been a leading chronicle of the frequency, volume, and causes of U.S. product recalls. The Recall Index covers recalls in the food, pharmaceutical, automotive, medical device, and consumer product industries.

With Q4 2017 marking the five-year anniversary of the Recall Index, the company looked at some of the longer term trends that have unfolded over the years, as well as several new findings from the latest quarter.

Overall Trends
The number of recalls across all industries has ebbed and flowed over the past five years, with 2016 being the most active year at 3,438 recalls.  

The volume of recalled units (the total number of individual products affected by a recall) climbed dramatically – by nearly one-third (32.6 percent) over the last five years, resulting in larger losses and risks for manufacturers. The number of recalled units increased across all industries except for medical devices, which experienced a decline of 79.7 percent. An improving economy, globalization, and growing consumer awareness are some of the contributing factors for increased recalled units.

"One thing didn't change over the past five years: consumers, manufacturers, regulators, and lawmakers remain concerned about the safety of products. What has changed is the public is paying more attention to the recall process and how effectively brands manage product recalls and notifications," said Mike Good, Vice President of Marketing & Sales Operations, Stericycle Expert Solutions. "The challenge now is overcoming the recall fatigue that occurs when consumers are faced with more – and larger – recalls. We created the Recall Index as a public service to help put recall trends in perspective so all stakeholders can make informed decisions grounded in facts."

Food & Beverage
The food and beverage industry experienced the most dramatic spike in units recalled over the past five years. Food products recalled by the U.S. Food and Drug Administration (FDA) skyrocketed 92.7 percent since 2012, and recalled pounds regulated by the U.S. Department of Agriculture (USDA), which largely oversees meat production, jumped 83.4 percent in the same period.

Technological improvements in food testing, combined with factory farming and growing automation in food production were major drivers of the increases. Undeclared food allergens and bacterial contamination such as listeria were the most consistent culprits that only worsened over the years. Approximately 28 percent of FDA food recalls were due to bacterial contamination in 2012, with that number jumping to 31.3 percent by year-end 2017. Undeclared allergens were the top cause of recalled pounds of food by the USDA in 2012 (35.4 percent), increasing to 41.2 percent five years later.

Bacterial contamination and undeclared allergens continued to be the main causes of food recalls in Q4 2017. But the good news is FDA recalls declined 5 percent to 150 in the last quarter – the lowest since Q1 2016. And while the number of USDA recalls increased slightly in the final quarter, the volume of recalled pounds dropped 92 percent to the lowest since Q3 2013.

Consumer Products
Sports/recreational activities and equipment were the most prevalent causes of recalls in the consumer products space over the past five years, including overturning All-Terrain Vehicles (ATVs), pool and spa entrapments, and unsafe playground equipment and surfaces. This category segment increased from 23.9 percent in 2012 to 32.4 percent in 2017.

However, the largest individual recalls were caused by gas cylinders. Nearly 30 million welding gas cylinders were recalled due to leaks that posed a fire hazard in 2012. In 2017, leaking propane gas cylinders were the top issue.

Q4 2017 stands out for being the first time since Q4 2013 that no fines were handed out by the Consumer Product Safety Commission. The quarter also saw a shift in product categories, with three large recalls in three categories – heating, cooling, and ventilating equipment; miscellaneous products; and home furnishings and fixtures – combining for 94.4 percent of all recalled units.

It's no surprise airbags have dominated automotive recall news over the past few years, with 16.9 million recalled units in 2017 alone. Five years ago, airbags were the third highest cause of recalled units, comprising just 10.2 percent of the total. Visibility was the leading cause of recalled automotive units in 2012, due mainly to malfunctioning windshield wiper arms and washing systems. Visibility problems have improved dramatically since, affecting just 0.3 percent of total recalled units in 2017.  

A few large individual recalls rather than broader causes tend to skew results in the pharmaceutical industry. In 2012, a 123-million-unit recall due to deviations in Current Good Manufacturing Practices (CGMPs) made up more than 75% of the year's recalled units. CGMPs are FDA regulations designed to help ensure drugs are manufactured safely and factor heavily into drug recalls if standards are not met. Likewise, in 2017, a single 148-million-unit recall due to sterility problems dominated the industry.

In Q4 2017, the story was the continued rise of Class I recalls – which are those posing the most serious health threat to consumers. Though this last quarter saw a drastic drop in units and recall size, the number of Class I units more than doubled from last quarter to just under 345,000.

Medical devices
Technological advances in medical devices have also been a major cause of recalls over the past five years. As manufacturers rush to be first-to-market with the latest innovations, software issues triggered a significant number of recalls.

Q4 2017 saw the software trend continuing. More than a quarter (25.7 percent) of all medical device recalls were due to software issues, making it the top cause for the seventh consecutive quarter.

Sterility issues were another leading factor, though this may be improving. The largest medical device recall in 2012 was almost twice the size of that in 2017. In 2012, 102 million devices were recalled due to sterility issues due to one recall. The largest medical device recall in 2017 was 54 million units, also caused by sterility problems.

The full Q4 2017 Recall Index is available for download:

About the Stericycle Recall Index
The Stericycle Recall Index is the only report that aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA, and the USDA. For more information, please visit

About Stericycle Expert Solutions
Stericycle Inc. is a NASDAQ-listed global business-to-business services company which provides highly specialized solutions to healthcare and commercial businesses of all sizes. Founded in 1989, Stericycle Inc. has grown to become a leader across a range of complex and highly regulated market sectors and operates in 550 locations. Stericycle Expert Solutions is the industry leader in managing automotive, consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Expert Solutions streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for leading global companies. For more information, visit


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