Medical Device Recalls
Update – November 21, 2024
CDRH announced a Communications Pilot to Enhance the Medical Device Recall Program 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.
Through the Communications Pilot to Enhance the Medical Device Recall Program, the FDA has committed to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. However, the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.
The FDA will keep the public informed and update our website as significant new information becomes available.
The FDA lists the most serious type of medical device recalls as well as early alert communications about corrective actions being taken by companies that the FDA believes are likely to be the most serious type of recalls on our website by the date that the FDA posts the information on our website.
Recent Medical Device Recalls and Early Alerts