How Early is Too Early? CDRH Expands Early Alert Communications for Potentially High-Risk Device Recalls

On September 29, 2025, FDA announced that it would be expanding its use of “Early Alert” communications for potentially high-risk device recalls, having determined that the pilot of this program was a success. The pilot program, initiated November 21, 2024, sought to minimize the time between FDA’s initial awareness of and public communication of potentially high-risk medical device recalls. Under the pilot, FDA issued Early Alerts for recalls related to a limited subset of medical devices: cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. As of this latest announcement, FDA will now issue Early Alerts for all medical device recalls that are likely to be classified as the most serious type.

Although FDA already publishes notifications of high-risk recalls after manufacturers submit formal 806 reports and FDA classifies the recall, this process generally results in notifications published 2-3 months after recall letters are sent to customers. Based on our review of recent early alerts issued under the pilot program, FDA has been able to bring this timing in to around 1-3 weeks after initial customer letters. To do this, FDA is likely relying on voluntary pre-notifications by companies of potential recalls before an 806 report has been submitted (and potentially before some companies have determined that a recall is even reportable to FDA).

FDA publicizes these Early Alerts on its website  for all Class I medical device recalls.  FDA includes the status of whether FDA still is “collecting information” about the recall, whether the recall has been confirmed, and whether there is new information that has been updated since the Early Alert first issued.  The database is easily searchable and can be exported to Excel.  The public also can subscribe to receive instant email notifications for new Early Alerts that are issued.

Overall, we do not expect that FDA’s expansion of this pilot program should materially change a company’s process for evaluating whether to initiate a recall or report it to FDA. But, companies should be prepared for FDA to issue public notice of high-risk recalls earlier in the process than before and potentially before a company submits a formal 806 report.