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U.S. Product Recalls Hits a 10-Year High, According to Sedgwick

While food recall events initiated by FDA declined 12.7%, their average size soared 328.4% to over 1.3 million units, Sedgwick said.

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MEMPHIS, Tenn. — According to Sedgwick brand protection’s latest U.S. product recall index report, more than 900 million units have already been recalled in these industries during the first quarter of 2022. Not only does this mark the highest number of units recalled in a single quarter in the past 10 years, but it also eclipses average annual figures recorded across this timeframe too.

U.S. regulators have started off 2022 with increased enforcement activity and stricter scrutiny over the automotive, consumer product, food and beverage, pharmaceutical and medical device industries.

Sedgwick brand protection’s quarterly report takes an in-depth look at the top challenges and regulatory developments that businesses need to know about to navigate an evolving recall environment. The report includes the latest product recall data and trends from the first quarter of 2022 plus insights, analysis and predictions from Sedgwick’s brand protection experts.

Highlights from the first quarter recall data:

  • There were 221 automotive recall events in Q1 2022, which is lower than the quarterly average for 2021. However, the number of units recalled rose sharply by 114.2% to 9.3 million.
  • The number of consumer product recalls jumped 63.8% in the first quarter of 2022, reaching their highest level in over five years. The number of units recalls increased 161.0%.
  • While food recall events initiated by the FDA declined 12.7%, their average size soared 328.4% to over 1.3 million units. Only one quarter in the past 12 years has experienced recalls greater in size. In contrast, the USDA was the only regulator to see the number of recalled units fall.
  • As with other industries, the number of medical devices recalled skyrocketed in the first quarter, increasing by 2,624.9%. Average recall sizes exceed 1.5 million units – a level witnessed only once before in the past 15 years.
  • Like medical devices, the average pharmaceutical recall hit a 15 year high, exceeding 4.6 million units per event. The total number of units recalled across the first quarter of 2022 surpassed 435 million – equally representing a 15 year high.

Looking ahead in 2022:

  • The automotive industry will likely see new regulations around autonomous vehicles and electric vehicles after NHTSA spent the quarter setting the foundation to improve vehicle safety. While new regulations could prove burdensome for manufacturers, additional safety measures will increase consumer confidence in these vehicles.
  • For the consumer product industry, children’s products will remain a focus for regulators and lawmakers with a new legislation focused on banning the sale of crib bumpers. Sustainability will be another key focus specifically related to greenwashing in the fashion industry.
  • Activity around infant formula will dominate the food and beverage industry, as the FDA continues to deal with a national shortage of the product and launches a review of its programs and policies for infant formula and special medical food complaints, illnesses and recalls. Additionally, regulators will continue to ramp up in-person inspections and other pre-pandemic operations.
  • In the pharmaceutical industry, lawmakers and regulators alike are focused on lowering drug prices. Lawmakers in both houses of Congress recently introduced legislation aiming to address anti-competitive behavior in the industry by increasing innovation and making drugs more affordable.

  • The FDA’s proposed rule to harmonize its Quality Systems Regulation and align U.S. medical device manufacturing standards with those of other nations will be the main regulatory focus of the year. Although many experts agree this will make it easier for device manufacturers, there are still concerns about the rule’s impact and the FDA’s timeframe for implementation.

“While most business operations have adapted to the challenges associated with the ongoing pandemic, new challenges continue to emerge that put businesses at risk. Businesses may also find themselves overwhelmed with the threats to their reputation and their financial success with increased regulatory activity from agencies and lawmakers,” said Chris Harvey, senior vice president at Sedgwick. “Companies should take every opportunity to evaluate and bolster their recall management, crisis and communications plans to ensure they are prepared for the next product crisis.”