Sedgwick brand protection releases a year-in-review analysis of 2024 recall data.

Summary

Medical device recalls reached a four-year high in 2024, with 1,059 events recorded, according to Sedgwick’s 2025 US State of the Nation Recall Index report. Across five key industries, there were 3,232 total recalls, marking the second-highest annual total in six years. Despite the rise in events, the number of defective units recalled fell to its lowest level since 2015. The report highlights regulatory and litigation trends shaping recall activity and notes that device failure was the leading cause of medical device recalls for the first time in over five years.

Key Takeaways

  • Medical Device Recalls at a Four-Year High – The sector saw an 8.6% increase in recall events, reaching 1,059 in 2024.
  • Device Failures Lead Recall Causes – Device failure accounted for 11.1% of medical device recalls, the highest rate in over five years.
  • Regulatory and Litigation Trends Emerge – Lawsuits and enforcement actions influenced recalls in 2024, with AI oversight expected to be a regulatory focus in 2025.

The medical device sector recorded a four-year high for recall events last year, according to Sedgwick brand protection’s 2025 US State of the Nation Recall Index report. 

The report identified 3,232 recalls across five key industries—including medical device with 1,059 recalls—representing the second-highest annual total in the past six years. The number of US product recalls remained high during 2024 with more than 3,200 events recorded for the second consecutive year. Notably, 2023 and 2024 are the only consecutive years in the past decade in which US recall events have exceeded 3,200. 

In contrast, the number of defective products recalled in 2024 fell to its lowest level since 2015, with 680.9 million units. This is a significant drop from the nearly 1.5 billion units that were recalled just two years earlier in 2022.

Sedgwick’s quarterly index report analyzes recall data from the automotive, consumer product, food and drink, pharmaceutical, and medical device industries. This special edition not only includes Q4 events but also provides a year-in-review analysis of 2024 recall data and product safety trends. Multiple industries reached significant recall milestones in 2024. The consumer products sector experienced its second-highest recall total in the past eight years, while the medical device sector recorded a four-year high for recall events with 1,059 recalls. 

In contrast, the food and drink industry under the US Department of Agriculture’s purview recorded the second lowest annual total in the last decade in 2024, despite setting a six-year high in terms of units impacted. Meanwhile, the pharmaceutical sector hit an 11-year annual low for the number of defective units recalled.

Medical Device Recalls By the Numbers

Key statistics from the report regarding the medical device sector indicate: 

  • Medical device recall events increased 8.6% in 2024, from 975 (in 2023) to 1,059.
  • Medical device recalls of a Class I severity are at a 15-year high.
  • Total impacted units surged 55.4%, from 283.4M in 2023, to 440.4M in 2024. With this increase, impacted units are at their highest rate in three years.

Top 5 Causes by Recall Events

The report pinpointed the top causes of medical device recalls based on the number of recall events. Device failure was the leading cause of recall activity in 2024. This marks the first time this has been the leading cause. The other top causes based on the number of recall events were:

  • Quality
  • Software
  • Mislabeling
  • Parts issue 

Regulatory Developments Influencing 2024

Beyond the recall data and analysis, this report also provides insights into the regulatory developments that influenced 2024 and forecasts what stakeholders should anticipate in 2025. Looking back at 2024, litigation emerged as a significant trend, with organizations filing lawsuits against government agencies and regulators pursuing criminal actions against companies and individuals related to recall and product safety issues. 

Artificial intelligence (AI) was another key focus for regulators across industries during 2024. That trend is expected to continue in 2025 as the US looks to keep pace with technological innovations while balancing user safety. It is uncertain if these enforcement and litigation trends will continue in 2025 under a new administration or how regulatory priorities may shift. 

“It is difficult to say exactly why the number of units recalled continues to fall while the number of product recalls remains high. Manufacturers may be producing smaller batches, overall production could be down, or improvements in traceability might be allowing companies to more accurately identify defective items,” says Chris Harvey, senior vice president of brand protection for Sedgwick, in a release. “As the new administration develops its agenda, companies may experience some uncertainty with regulatory priorities. In the face of change, it is essential for companies to continue to routinely plan and practice for product recalls and in-market crises.”

ID 210871921 © Awargula | Dreamstime.com