State of the Nation 2025: Global Medical Device Recall Index Report
By Sedgwick
Gain unparalleled insight into one of the most highly regulated and rapidly evolving sectors—medical devices. This special edition of Sedgwick’s globally recognized Recall Index Report delivers data, trends, and strategic forecasts from 2024, with analysis spanning the U.S., EU/UK, and Australia.
Whether you manufacture, distribute, or oversee compliance in the medical device space, this report provides critical recall statistics, regulatory updates, and legal developments that could significantly impact your risk exposure, product planning, and go-to-market strategy. With record-high recall volumes, new AI and telehealth regulatory guidelines, and sweeping global changes on the horizon, this is essential intelligence for anyone in the industry.
Key insights include:
- U.S. recalls reached a four-year high, with Class I recalls at a 15-year peak.
- Software and device failure were leading causes of recalls across all regions.
- Major legal and regulatory shifts, including AI guidance, decentralized clinical trials, and environmental mandates.
- In-depth analysis of litigation, compliance challenges, and opportunities for innovation.
Don’t wait for a product crisis to find out if you’re prepared. Use this report to benchmark your organization’s readiness, strengthen your brand’s defenses, and get ahead of what’s next.
👉 Available exclusively to AdvaMed members.
Disclaimer: This report is produced by Sedgwick and is provided as a benefit of AdvaMed Associate Membership. AdvaMed does not endorse the content or conclusions of this report. Associate members are allowed to post whitepapers and reports to the resource center as part of their membership benefits. resource center as part of their membership benefits.