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FDA Announces Expansion of Early Alert Communications to All CDRH Medical Devices

Today, the U.S. Food and Drug Administration (FDA) announced the expansion of CDRH’s Communications to Enhance the Medical Device Recall Program. Effective Sept. 29, 2025, CDRH will issue Early Alert Communications for all medical devices.

The program is intended to minimize the time between FDA's initial awareness of and public communication of potentially high-risk medical device removals or corrections. Providing more timely notice of potential high-risk recalls will help health care facilities, distributors, and other stakeholders take prompt action to address serious medical device safety issues.

This effort reflects our commitment to providing clear and timely notifications to patients, consumers, and health care providers about the safety and effectiveness of medical devices.

Questions?

If you have questions about CDRH recalls or early alerts, contact the Division of Industry and Consumer Education.