2025 Medical Device Recall Index Report: Navigating Challenges and Opportunities
The medical device sector faces constant evolution, presenting both challenges and opportunities for manufacturers and stakeholders. The 2025 edition of Sedgwick’s Global Medical Device Recall Index Report provides critical insights into the current landscape, analyzing data, trends, and strategic forecasts from 2024 focused on the U.S., EU/UK, and Australia.
This report, available exclusively to AdvaMed members, is essential for anyone involved in the medical device industry. It provides key recall statistics, regulatory updates, and an overview of the legal developments that could influence risk exposure, product strategies, and go-to-market plans.
Key Findings and Analysis:
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The analysis reveals a four-year high in U.S. recalls, with Class I recalls reaching a 15-year peak.
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Software failures and device malfunctions led as primary causes of recalls across all regions.
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The report highlights new legal and regulatory changes including AI guidelines, decentralized clinical trials, and environmental mandates.
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An in-depth analysis of litigation, compliance challenges, and emerging opportunities for innovation are also included.
This report helps organizations benchmark their readiness, improve their brand defenses, and stay ahead of industry developments.
Note: This report is produced by Sedgwick and provided as a member benefit of AdvaMed. AdvaMed does not necessarily endorse the content or conclusions of this report.
