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

• 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.