Healthcare Scare: Medical Device and Pharmaceutical Recalls Spike

Tuesday, May 8, 2018 Medical Gadgets
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Stericycle Expert Solutions' Q1 2018 U.S. Recall Index reveals top causes included software issues and failed specifications

INDIANAPOLIS, May 8, 2018 /PRNewswire/ -- A significant spike in product recalls rocked the healthcare industry

in the first quarter of 2018 as both pharmaceutical and medical device companies experienced an unusually high number of problems, according to the latest U.S. Recall Index released today by Stericycle Expert Solutions (NASDAQ: SRCL). The Recall Index covers recalls in the food, pharmaceutical, automotive, medical device, and consumer product industries.

Medical device recalls increased 126 percent to 343 in Q1 2018, more than double the last quarter and the largest quarter since 2005. The biggest culprit for medical device recalls was software, which comprised 22.7 percent, making it the top cause for the eighth consecutive quarter.

Pharmaceutical recalls increased 52 percent to 105, making it the highest number of recalls since Q3 2013. Failed specifications were the top cause of drug recalls for the seventh consecutive quarter, comprising nearly 22 percent of all pharmaceutical recalls.

"The healthcare sector in Q1, both medical device companies and pharmaceutical manufacturers, saw significant increases in recall events," said Mike Good, Vice President of Marketing & Sales Operations, Stericycle Expert Solutions. "Issues ranging from software to mislabeling in med device, to failed specs and foreign materials in pharmaceuticals caused pretty dramatic spikes and show that you have to be vigilant and act on recalls when they happen, especially when your health is on the line."

Dangerous décorConsumer product recalls were fairly consistent in Q1 2018, with just a three percent decrease in recalls. While sports and recreational equipment has been the leading cause of recalls for the past four quarters, home furnishings and décor jumped to the top spot in Q1, comprising 29.2 percent of all consumer recalls. Fire and laceration were the top hazards that threatened consumers.

Heavy metalRecalls in the food and beverage sector remained relatively steady. FDA food recalls declined slightly by eight percent to 138, while the number of food units pulled from the market increased just six percent. USDA recalls stayed equal at 28, though the total of recalled pounds of beef, poultry, pork, seafood and other products under the USDA's watch increased 69% to just over one million.

Beef was the top category for USDA recalled pounds for the first time since Q1 2016, breaking up a two-quarter streak for multiple proteins. Flavoring was the top category for recalled FDA units at 43.3%, up from just 0.6% in Q4 2017.

At 53 percent, contamination from foreign materials – particularly metals found in food – was the leading cause of recalled FDA units, while bacterial contamination was the top reason (58 percent) for USDA recalled pounds.

Airbags ascendDefective airbags continue to plague the automotive sector. While automotive recalls increased just one percent to 215 in Q1 2018, more than 63 percent of all recalled units were due to airbags, making it the highest percentage since Q1 2017. Steering issues were the second most prevalent cause based on units recalled. Just five car manufacturers were responsible for half (49.9 percent) of all automobile VINs that issued recalls.

The full Q1 2018 Recall Index is available at

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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SOURCE Stericycle Expert Solutions

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