Medical Device Safety
Update – November 21, 2024
CDRH is announcing a communications pilot to enhance the medical device recall program and to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. The pilot will include early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.
The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).