Sedgwick brand protection releases full year of U.S. product recall data and analysis

Memphis, Tenn., March 2, 2023 – For the second consecutive year, more than 1 billion units of food, drugs, medical devices, automobiles, and consumer products were recalled in the U.S. According to Sedgwick’s latest state of the nation recall index report, 2022 was a record-breaking year for the number of units recalled, reaching nearly 1.5 billion. With regulatory scrutiny continuing to increase, 2023 may shape up to be another 1 billion unit year, requiring businesses across industries to remain vigilant on matters of product safety and recall preparedness.

This special edition of Sedgwick’s recall index report goes beyond its traditional quarterly reviews, offering a year-in-review analysis of 2022 recall data and trends. The report also provides essential insights and predictions from Sedgwick’s brand protection experts and network of strategic partners on the legal, regulatory and economic risks facing the automotive, consumer product, food and beverage, medical device, and pharmaceutical industries in 2023.

2022 recall data highlights

• Automotive recalls decreased 12.6% in 2022 compared to 2021. The sector also experienced a 10.3% decline in the number of units recalled, marking a nine-year low.
• While the number of consumer product recalls increased by nearly a third (31.2%) in 2022 over 2021, the number of units recalled almost halved (45.4%), from 42.8 million in 2021 to 23.4 million in 2022.
• FDA food recalls experienced a 700.6% increase in the number of units impacted in 2022. With 416.9 million units recalled, this represents a 10-year high. While the United States Department of Agriculture (USDA) food recalls held steady in terms of the number of events, the volume of units recalled decreased significantly (87.0%) from 13.4 million pounds in 2021, to 1.7 million pounds in 2022.
• While pharmaceutical recall events increased by a third (32.5%) in 2022, the number of impacted units recalled more than doubled (114.4%) to 567.3 million. This marks a 10-year high for the industry.
• Recall events in the medical device industry increased by 8.8% in 2022, up from 837 events in 2021 to 911. The number of units impacted decreased 27.2% from 2021 to 438.7 million units in 2022.
• Electric vehicles (EVs) will remain a key focus for the automotive industry, regulators, and lawmakers in 2023, as the U.S. continues to move towards a zero emission future. Manufacturers may also find their vehicle’s “smart features” the target of new regulations, as cybersecurity becomes a greater threat in increasingly connected vehicles. With experts recommending that industry standards should be developed, regulators may begin work on this task in 2023.
• The consumer product industry will likely see continued strict regulatory enforcement from the Consumer Product Safety Commission (CPSC) in 2023, building on a year of civil penalties and attention-grabbing press releases. Other regulatory agencies are taking an interest in consumer products, with the Environmental Protection Agency (EPA) looking at PFAS and the Federal Trade Commission (FTC) considering tightening greenwashing oversight.
• 2023 will bring new uncertainties for the food and beverage industry, as the Food and Drug Administration (FDA) announced plans to overhaul the food side of the agency and place food policy and regulation under one deputy commissioner. Manufacturers and suppliers will need to watch this process closely to evaluate any resulting regulatory or policy changes.
• Medical device manufacturers will face increased responsibilities for reporting how they will monitor, identify, and address post-market cybersecurity vulnerabilities. Adapting regulations to meet advancements in technology will be another area to watch for manufacturers, as the FDA will now require all 501(k) submissions to use the digital eSTAR format.
• Two acts passed at the end of 2022 under the Consolidated Appropriations Act, 2023 (H.R. 2617) will introduce numerous new obligations for pharmaceutical manufacturers around issues such as marketing, clinical trials, and the FDA’s authority. The industry will also need to contend with a full Unified Agenda from the FDA, which included 87 short- and long-term actions such as proposed and final rulemakings.

What’s ahead in 2023

“The year ahead will likely be characterized by the same strict regulatory enforcement that all industries saw in 2022,” shared Chris Harvey, Sedgwick senior vice president of brand protection. “Regulators have now fully returned to pre-pandemic levels of activity and are making up for lost time with a steady slate of long awaited guidelines and modernizations to existing regulations. Businesses will face the tough challenge of remaining agile with their operations to accommodate new regulations, while simultaneously anticipating and preparing for potential economic and geopolitical issues.”

The recall index is published every quarter by Sedgwick’s brand protection experts. It is the only report that aggregates and tracks recall data across multiple regulatory agencies and industries to help industry stakeholders navigate the regulatory environment, product recalls, and other in-market challenges. For more information, please visit www.sedgwick.com/brandprotection.

To download the latest recall index, visit U.S. state of the nation recall index.