Product Recalls Reached Five-Year High in 2023, Sedgwick Report Says

Product recalls across several various sectors experienced record breaking product recalls, according to a recent Sedgwick report. Regulatory changes within the last year could serve as the reasoning for the five-year high.
By: | March 14, 2024
Topics: News + Notes

The number of product recall events hit a five-year high in 2023, even though the number of defective units included in the recalls was sharply lower, according to Sedgwick’s 2024 State of the Nation report.

There were 3,301 total recall events last year, with five industries — automotive, consumer products, food and drink, medical devices and pharmaceuticals — leading the list of categories involved.

Despite more recalls last year, Sedgwick found that the number of units included in recalls had dropped nearly in half, to 759.36 million units, from a record volume of 1.48 billion affected units in 2022.

Sedgwick noted that businesses should be aware of increased regulatory activity in several areas, which might affect product recalls. For example, the report noted increased collaboration between federal agencies and state attorneys general behind recall efforts.

“In April, a group of AGs wrote a letter to the National Highway Traffic Safety Administration (NHTSA) trying to prompt a recall of certain vehicles that lacked a specific anti-theft device. The AGs wanted NHTSA to intervene because they felt the automakers were not doing enough,” the report said.

And in November, 25 state AGs asked the U.S. Food and Drug Administration (FDA) to take action to address pulse oximeter inaccuracies for people with dark skin pigmentation. The original issue was raised almost two years earlier and the AGs argued the delay was creating unnecessary health risks.

The increasing use of artificial intelligence and machine learning (AI/ML) also attracted regulatory scrutiny, according to the report.

Regulators looked at potential consumer risk from AI technologies in various products, and the Biden Administration secured a voluntary commitment from leading AI companies to focus on safety, security, and trust. The FDA addressed the use of AI/ML in drug and biological product development and the marketing approval process for AI/ML-enabled medical devices.

Cybersecurity was a significant issue for automakers as vehicles increasingly use more software and apps, and it was also important for consumer products to prevent hacking and compromising safety, the report said. The Federal Communications Commission (FCC) and Biden Administration introduced the U.S. Cyber Trust Mark program, while the FDA introduced new cybersecurity requirements for medical devices.

In response to the 2022 infant formula crisis, the FDA restructured its Human Foods Program and updated definitions and processes in areas such as organics and the “Generally Recognized As Safe” list of food additives. The FDA is investigating lead contamination in applesauce after initial reports in October 2023, and the agency has recalled three brands of cinnamon apple puree as a result.

Meanwhile, other product safety regulatory trends expected to continue through 2024 include more regulation for online sellers and secondary markets, holding online retailers and platforms accountable for protecting consumers from fraudulent claims and dangerous products.

The Sedgwick report provided key details on 2023 recall activity in top categories:

  • Medical devices: 975 recalls, up 7% from 2022. Quality concerns with medical devices was to blame for 152 recalls, or 15.6% of the total. The number of defective devices included in medical recalls dropped 35.3% to 438.4 million in 2023.
  • Automotive: 916 recall events in 2023, down 4.1% from 2022. Electrical system issues in EVs was the leading case of automotive recalls, accounting for 193 recalls, or 21.2% of the total. Despite fewer recalls, the number of impacted units increased to 38.4 million in 2023, from 31.2 million a year earlier.
  • Pharmaceuticals: 517 recalls, up 42.4% over the previous year. This marked the higher number of pharmaceutical recalls in more than 10 years, Sedgwick noted. Sterility of medicines was the leading issue behind recalls, accounting for 137 events, or 26.5% of recalls. Despite more recalls, the number of defective units dropped to 98.5 million, an 82.6% drop over 2022.
  • Food and Drink: 506 recalls last year, up 19.6% from 2022, making 2023 the highest number of recalls in five years, Sedgwick noted. Undeclared allergens was the leading cause of food recalls in 2023, accounting for 232 events, or 45.8% of the total number of events. But the number of impacted units fell to 199.7 million last year from 416.9 million in 2022.

As the regulatory landscape continues to evolve, industries must remain vigilant and adaptable to ensure consumer safety and compliance with new regulations and guidelines, Sedgwick said.

To access the full report from Sedgwick, click here. &

The R&I Editorial Team can be reached at [email protected].

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