Critical Medical Device Recalls of 2025: Compliance Lessons and Litigation Risks for Manufacturers

The medical device industry continues to face significant challenges as major recalls from 2024-2025 transition into complex litigation and regulatory investigations that will shape compliance requirements throughout 2026. For medical device manufacturers, understanding the patterns behind these recalls and their legal ramifications is crucial for maintaining robust quality systems and avoiding similar pitfalls.

The Expanding Impact of Recent Device Recalls

Recent data indicates that several high-profile medical device recalls from the past two years are now generating substantial legal activity, with lawsuits and FDA investigations expected to intensify through 2026. These cases represent more than isolated incidents—they reveal systemic issues in post-market surveillance, risk management, and quality assurance that manufacturers must address proactively.

The financial and reputational consequences of these recalls extend far beyond immediate remediation costs. Legal proceedings can drag on for years, creating ongoing compliance burdens and potential regulatory scrutiny that affects future product approvals and market access.

Key Compliance Vulnerabilities Exposed

Analysis of recent recalls reveals several critical areas where manufacturers’ compliance systems failed:

• Inadequate Post-Market Surveillance: Many recalls could have been prevented with more robust monitoring systems that detect adverse events and device malfunctions earlier
• Deficient Risk Management Processes: ISO 14971 risk management files that failed to adequately assess and control foreseeable hazards
• Poor Supplier Controls: Component quality issues that weren’t caught due to insufficient supplier qualification and ongoing monitoring
• Documentation Gaps: Incomplete design controls and verification/validation records that complicated recall investigations

Regulatory Response and Enforcement Trends

The FDA’s response to these recalls demonstrates an increasingly aggressive enforcement posture. Manufacturers are seeing:

• More comprehensive inspections focusing on quality management system effectiveness
• Increased use of untitled letters and warning letters for systemic CAPA failures
• Enhanced scrutiny of 510(k) submissions from companies with recent recall history
• Greater emphasis on post-market study requirements for approved devices

Essential Action Steps for Manufacturers

To mitigate litigation risk and maintain regulatory compliance, medical device manufacturers should immediately implement these critical measures:

Strengthen Post-Market Surveillance

Enhance your complaint handling and adverse event monitoring systems. Implement proactive surveillance programs that go beyond minimum MDR reporting requirements. Consider leveraging real-world evidence and post-market clinical studies to identify potential safety signals early.

Audit Risk Management Files

Conduct comprehensive reviews of existing ISO 14971 risk management files, particularly for devices similar to those recently recalled. Ensure risk controls remain effective and that post-market data is incorporated into ongoing risk assessment updates.

Evaluate Supplier Relationships

Review supplier agreements, qualification processes, and ongoing monitoring procedures. Many recent recalls traced back to component suppliers whose quality systems weren’t adequately controlled by the device manufacturer.

Prepare for Increased Scrutiny

Expect more rigorous FDA inspections and be prepared to demonstrate the effectiveness of your quality management system. Ensure CAPA processes can identify and address systemic issues, not just isolated incidents.

Legal Preparedness Considerations

Given the litigation trends emerging from recent recalls, manufacturers should also:

• Review insurance coverage for product liability and recall expenses
• Establish clear document retention policies that balance legal discovery obligations with business needs
• Train staff on proper incident documentation to avoid creating unnecessary legal exposure
• Develop crisis communication plans that coordinate regulatory, legal, and business responses

Looking Ahead: Building Resilient Compliance Systems

The recalls and litigation of 2025 serve as a wake-up call for the entire medical device industry. Manufacturers that invest now in robust quality systems, proactive risk management, and comprehensive post-market surveillance will be better positioned to avoid similar crises and maintain patient trust.

The regulatory landscape continues to evolve, with FDA modernizing its oversight approaches and international harmonization efforts creating new compliance requirements. Companies that view compliance as a competitive advantage—rather than a cost center—will emerge stronger from this challenging period.