U.S. Product Recalls Reach Highest Quarterly Total in Past Five Years

Staff Report From Georgia CEO

Thursday, May 16th, 2024

Amidst stricter regulatory oversight and closer consumer scrutiny, U.S. product recalls increased eight percent quarter-over-quarter in Q1 2024. According to Sedgwick brand protection's latest U.S. Recall Index report, there were 909 recalls across five key industries in Q1, the highest single-quarter total in over five years. In contrast, the number of defective units fell 44.0% across all five industries, from 230.7 million in Q4 2023 to 129.6 million in Q1 2024.

Sedgwick's industry-leading Recall Index report offers in-depth analysis of the latest product recall data, safety regulations, and key challenges for the automotive, consumer product, food and drink, medical device, and pharmaceutical industries. Released quarterly, the report features unrivaled analysis and exclusive perspectives from Sedgwick's brand protection experts and network of strategic partners, the Index is a key resource in helping mitigate recall risk, litigation, and reputational damage caused by product crises and in-market events.

Product recall highlights from Q1 2024

  • Automotive recalls increased 9.2% quarter-over-quarter, with 262 events in Q1 2024. However, the number of units impacted fell 15.2%, from 14.7million in Q4 2023 to 12.5 million in Q1 2024. Electrical systems were the leading cause of recalls for the fifth consecutive quarter.

  • There were 92 consumer product recalls in Q1 2024, a 5.7% increase from the previous quarter. In contrast, the number of units impacted fell 71.8% from Q4 to 23.4 million, although the previous quarter marked a six-year high for units impacted.

  • The number of U.S. Food and Drug Administration (FDA) recalls rose 27.6% quarter-over-quarter to 134 events in Q1 2024. Only three quarters in the past five years have recorded a higher number. There were 51 recalls for undeclared allergens, making it the leading cause of food recalls. On the other hand, U.S. Department of Agriculture (USDA) recalls fell 31.6% from Q4 2023 to 13 recalls in Q1 2024. The weight of units impacted increased by 22.1% to 378,055 pounds in Q1 2024.

  • The medical device industry recorded 296 recalls in Q1 2024, up 13.8% quarter-over-quarter. This is the second-highest quarterly total in over five years. Conversely, the number of units recalled fell 51.2% from 109.4 million to 53.4 million.

  • The pharmaceutical industry saw recalls decrease 14.5% in Q1 2024 to 112 events, down from 131 last quarter. The number of units recalled also fell in Q1, down 46.3% from 17.3 million to 9.3 million.

Looking ahead

  • Automotive: Throughout the remainder of 2024, the automotive industry will confront numerous challenges as regulators push for cleaner, greener vehicles. Automakers will be faced with pressure from lawmakers and regulators to accelerate the transition to electric vehicles (EVs) while balancing the shifting consumer demand for gas-powered and hybrid vehicles. Heightened political tensions amidst an election year in the U.S. is set to complicate the situation further.

  • Consumer product: Stakeholders in the consumer product industry can expect more aggressive actions from both the Consumer Product Safety Commission (CPSC) and the Federal Trade Commission (FTC) throughout 2024. Both agencies now have a full five-person Commission and have outlined ambitious regulatory agendas for the remainder of the year. Additionally, the $16M fine levied by the CPSC in Q1 suggests the possibility of 2024 exceeding the record $55.3M fines of 2023.

  • Food and drink: In 2024, the FDA, USDA, and FTC are developing measures that are working to keep consumers safe and provide them with accurate information about the food they are buying. However, the new measures also illustrate how many entities are involved in food safety and the complexities the food industry faces. Stakeholders will need to closely monitor regulatory activity and enforcement actions.

  • Medical device: Medical device companies are facing several potentially onerous new regulations that will begin to take effect throughout the year. The FDA continues to work on new regulations regarding quality management systems, laboratory-developed tests, and marketing authorization submissions. However, certain details within the FDA's proposals remain ambiguous, heightening the complexity for medical device companies to ensure compliance.

  • Pharmaceutical: The FDA is working on product-specific rules for benzene, marijuana, and other items. Additionally, the agency has been focused on reducing drug shortages, which have become a problem for the U.S., the European Union, and other countries post-COVID. It is imperative for manufacturers to assess the potential implications of these forthcoming regulations on their operations and supply chain partners to proactively adapt to the new regulatory landscape.

"Regulators have started off 2024 as expected, continuing the high rate of enforcement activity and introducing new regulations and rules to improve product safety amidst an ever-growing list of risks," said Chris Harvey, Senior Vice President of Brand Protection for Sedgwick. "As responsibilities increase for stakeholders at every level of the supply chain, ensuring compliance and maintaining product safety and quality assurance will require all parties to work together to weather the risks."

To download the latest Recall Index report, visit Sedgwick's U.S. 2024 Edition 1 Recall Index page.

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