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Memphis, Tennessee. According to the latest report from Sedgwick Brand Advocacy. US Product Recall Index reportmore than 900 million devices were already recalled in these industries during the first quarter of 2022. Not only is this the highest number of devices recalled in a single quarter in the last 10 years, it dwarfs the annual averages recorded in that period too.

U.S. regulators began 2022 with increased enforcement and stricter oversight of the automotive, consumer goods, food and beverage, pharmaceutical, and medical device industries.

Sedgwick’s quarterly Brand Protection report details key issues and regulatory changes that businesses need to be aware of in order to navigate the changing review environment. The report includes the latest data and recall trends for the first quarter of 2022, as well as insights, analysis and forecasts from Sedgwick brand protection experts.

Highlights of the first quarter data recall:

  • There were 221 vehicle recalls in the first quarter of 2022, below the 2021 quarterly average. However, the number of recalled vehicles rose sharply by 114.2% to 9.3 million.
  • Consumer product recalls jumped 63.8% in the first quarter of 2022, reaching the highest level in five years. Device recalls increased by 161.0%.
  • While food recalls initiated by the FDA fell 12.7%, their average size rose 328.4% to over 1.3 million units. Only one quarter in the last 12 years has had a larger recall. In contrast, the USDA was the only regulator to see a decrease in the number of recalled units.
  • As with other industries, the number of medical device recalls skyrocketed in the first quarter, up 2,624.9%. Average recall volumes exceed 1.5 million units, a level that has only been seen once in the last 15 years.
  • As with medical devices, the average pharmaceutical recall rate hit a 15-year high of over 4.6 million units per event. The total number of units recalled in the first quarter of 2022 exceeded 435 million units, also representing a 15-year high.

Looking ahead in 2022:

  • The auto industry is likely to see new regulations on autonomous vehicles and electric vehicles after the NHTSA spent the quarter laying the groundwork for improved vehicle safety. While the new regulations may prove burdensome for manufacturers, the additional safety measures will increase consumer confidence in these vehicles.
  • In the consumer goods industry, baby products will remain a focus for regulators and legislators as new legislation aims to ban the sale of crib bumpers. Sustainability will be another key area, especially related to greenwashing in the fashion industry.
  • Infant formula activity will dominate the food and beverage industry as the FDA continues to address product shortages in the country and launches a review of its infant formula programs and policies and claims of complaints, illnesses, and reviews of special medical nutrition. In addition, regulators will continue to ramp up personal checks and other pre-pandemic operations.
  • In the pharmaceutical industry, both legislators and regulators are focused on lowering drug prices. Legislators in both houses of Congress recently introduced legislation aimed at combating anti-competitive behavior in the industry by expanding innovation and making medicines more affordable.

  • The Food and Drug Administration’s (FDA) proposed rule to harmonize its Quality Systems Statement and align U.S. medical device manufacturing standards with those of other countries will be the focus of regulatory attention this year. While many experts agree that this will make life easier for device manufacturers, there are still concerns about the impact of the rule and the implementation timeline set by the FDA.

“While most business operations have adapted to the challenges of the ongoing pandemic, new challenges continue to emerge that put businesses at risk. Companies may also face threats to their reputation and financial success from increased regulatory activity from agencies and legislators,” said Chris Harvey, Sedgwick Senior Vice President. “Companies should take every opportunity to evaluate and strengthen their feedback management, crisis and communications plans to ensure they are prepared for the next product crisis.”

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