On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to minimize the time between the FDA’s initial awareness of a potentially high-risk medical device removal or correction and the agency’s public communication of what was potentially a high risk recall, the most serious kind of recall. While the FDA may not have determined that a company’s actions had met the regulatory definition of a recall, the “Early Alert” communications included information on when companies removed products from the market, corrected products, or updated instructions for using products due to potentially high safety risks. Known as the Early Alert Pilot, it was developed as part of CDRH’s ongoing efforts to enhance the recall program as outlined in the 2024 Safety Report, and following recommendations from the Patient Engagement Advisory Committee (PEAC) meeting held Oct. 6, 2021. The program was designed using feedback from patients, health care providers, and consumers to make recall communications more timely, clear, and action-oriented.
After the success of the pilot, Early Alert communications expanded on Sept. 29, 2025, and CDRH will now issue Early Alerts for potentially high-risk removals or corrections for all medical devices.
Publication of Early Alerts is another example of CDRH’s commitment to providing clear and timely notifications to patients, consumers, and health care providers about the safety and effectiveness of medical devices. The FDA will keep the public informed and update our website as significant new information becomes available.
