Summary: U.S. product recalls increased by eight percent in Q1 2024, with the medical device industry seeing a 13.8% rise in recalls despite a 51.2% drop in defective units. Stricter regulations and increased enforcement are key factors.

Key Takeaways:

  • Increase in Recalls: Medical device recalls rose by 13.8% in Q1 2024, indicating heightened regulatory scrutiny.
  • New Regulations: Upcoming FDA regulations on quality management and tests add compliance challenges for medical device companies.

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.

Surge in Recalls Despite Fewer Defective Units

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. 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.

New Regulations Challenge Medical Device Companies

Medical device companies are facing several 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, according to Sedgwick.

Increased Regulatory Activity

“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.”

Sedgwick’s quarterly 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.