FDA Expands Early Alert Program to Cover All High-Risk Medical Device Recalls

The FDA has broadened its early alert communication initiative to include potentially high-risk recalls or corrections for all medical devices, following a successful pilot program. The pilot, launched late last year, initially focused on five therapeutic areas—cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. Early alerts were designed to reduce the delay between a company notifying customers of a device issue and the FDA issuing an official recall notice, which can sometimes take months.

The pilot demonstrated its value, prompting the FDA to lift the previous restrictions. Since its launch, 19 early alerts have been issued, including four in the past two weeks, covering companies such as Abbott, BD, and Johnson & Johnson’s Abiomed. Early alerts provide timely information about safety concerns while the agency works to classify and formally communicate recalls, helping healthcare providers and patients act more quickly to mitigate risk. The program now applies to all medical devices with potentially high-risk safety events.

07-10-2025