H.R. 6594: New Medical Device Recall Improvement Act Could Transform FDA Notification Requirements

On December 10, 2025, Representative Janice D. Schakowsky introduced H.R. 6594, the Medical Device Recall Improvement Act of 2025, marking a significant potential shift in how medical device recalls are managed and communicated. This proposed legislation aims to modernize the FDA’s recall notification system through electronic mechanisms, potentially impacting every medical device manufacturer’s recall preparedness and response protocols.

What the Medical Device Recall Improvement Act Proposes

The bill focuses on establishing an electronic notification system for medical device recalls, moving away from traditional paper-based and fragmented communication methods. While the full text details are still emerging, the legislation appears designed to create more streamlined, immediate, and comprehensive recall notifications that could reach healthcare providers, patients, and regulatory bodies simultaneously.

Key anticipated components include:

• Implementation of a centralized electronic recall notification platform
• Enhanced real-time communication capabilities between FDA and stakeholders
• Improved tracking and documentation of recall effectiveness
• Standardized notification protocols across different device classes

Why This Matters for Medical Device Manufacturers

Current recall notification processes under 21 CFR Part 806 often involve multiple communication channels, varying response times, and inconsistent information delivery. Medical device manufacturers frequently struggle with ensuring all affected parties receive timely, accurate recall information, which can impact patient safety and regulatory compliance.

This proposed legislation could fundamentally change how manufacturers must:

• Structure their recall communication strategies
• Maintain recall documentation and audit trails
• Coordinate with FDA during recall events
• Track recall effectiveness and completion rates

Regulatory Context and Current Challenges

Under existing FDA regulations, medical device recalls follow a three-class system based on potential health risks. Class I recalls involve devices that could cause serious injury or death, while Class II and III recalls address progressively lower risk scenarios. However, the current notification system often relies on traditional methods that may delay critical safety information from reaching end users.

Recent high-profile recalls, including ventilator recalls during the COVID-19 pandemic and various implantable device issues, have highlighted gaps in notification speed and effectiveness. The proposed electronic system could address these challenges by providing immediate, trackable communication channels.

Immediate Actions for Medical Device Manufacturers

While H.R. 6594 is still in early legislative stages with one cosponsor, proactive manufacturers should begin preparing for potential changes:

Short-term preparations:

• Review current recall procedures: Audit existing recall communication plans and identify potential integration points for electronic systems
• Assess technology capabilities: Evaluate current IT infrastructure’s ability to support real-time electronic notifications
• Update contact databases: Ensure customer and distributor contact information is current and electronically accessible
• Train recall teams: Prepare quality assurance and regulatory affairs teams for potentially faster-paced recall notification requirements

Long-term strategic considerations:

• Technology investment planning: Budget for potential system upgrades or new software platforms
• Process standardization: Develop standardized recall communication templates compatible with electronic systems
• Cross-functional coordination: Strengthen relationships between IT, quality, regulatory, and customer service departments

Next Steps and Timeline

As H.R. 6594 progresses through the legislative process, medical device manufacturers should monitor its development closely. The bill will need to pass through committee review, potential markup sessions, and floor votes in both chambers before reaching the President’s desk.

Key milestones to watch include committee assignments, hearing schedules, and any amendments that could affect implementation timelines or technical requirements. Manufacturers should also engage with industry associations like AdvaMed or MDMA to provide input on practical implementation challenges.

Preparing for the Future of Recall Management

Regardless of this specific legislation’s ultimate fate, the trend toward digital transformation in medical device regulation is clear. Forward-thinking manufacturers who invest now in robust electronic communication systems, comprehensive data management, and streamlined recall processes will be better positioned for future regulatory requirements.

The Medical Device Recall Improvement Act of 2025 represents more than just a procedural change—it signals a fundamental shift toward more transparent, efficient, and effective recall management that prioritizes patient safety through improved communication technology.