FDA Pilot Program Updates Recall Reporting

Recall Communication “Early Alerts”

Note: This summary is based on an FDA communication attributed to Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH).

In November 2024 the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) introduced a new pilot initiative aimed at improving how and when the public is informed about potentially dangerous medical devices.

The program provides early alerts when manufacturers take corrective actions on devices that the FDA considers to be high-risk—even before a full recall is publicly announced. These actions might include:

• Pulling a device off the market
• Issuing revised instructions for use
• Fixing a device design or performance issue

These alerts are meant to give healthcare providers and patients faster notice of emerging safety issues – especially in areas like cardiovascular, gastro-renal, general hospital, OB-GYN, and urology devices.

Why This Matters

Until now, there has often been a gap between when the FDA learns about a serious safety issue and when the public is notified. The new Communications Pilot Program aims to close that gap and improve transparency, trust, and patient safety.

CDRH Director Dr. Michelle Tarver, emphasized the importance of this step:

“This pilot demonstrates the FDA’s continued commitment to minimizing the time between identifying a potentially high-risk issue and getting that information to the public.”

This new program is part of a broader effort to modernize how the FDA handles medical device recalls, inspired in part by recommendations from the Patient Engagement Advisory Committee (PEAC). Patient voices have played a major role in shaping this pilot, reflecting a regulatory shift toward more patient-centered decision-making.

Building on a Strong Foundation

The pilot builds on years of work to strengthen the recall process. Since 2009, the FDA has:

• Released guidance for manufacturers to ensure devices remain safe and compliant.
• Partnered with patients, clinicians, and industry to improve how safety messages are communicated.
• Held public meetings (like the one in September 2023) to gather feedback on how to modernize medical device recall communications.

What’s Next?

Although this pilot currently focuses on a select group of device types, it marks a significant shift in how the FDA approaches device risk communication. It reinforces the agency’s commitment to acting proactively, not just reactively, when it comes to patient safety.

As the pilot progresses, the FDA will continue working with stakeholders—including manufacturers, healthcare professionals, and patient communities—to ensure that early warnings are both accurate and actionable.

Click here to learn more about this program.

For updates and alerts on high-risk device issues, visit the FDA’s Medical Device Recalls page.