Medical Device Recalls in 2024: Regulatory Challenges and Industry Impact

In 2024, medical device recalls have been a focal point for regulators and industry stakeholders, with notable actions from the FDA. Philips continued its massive recall of respiratory devices, including CPAP machines, which began in 2021 and became one of the largest product recalls in history. The U.S. Government Accountability Office (GAO) took a closer look at the FDA's oversight of these recalls, especially after concerns about the efficacy of its recall process surfaced. In response, the FDA, under new leadership from Michelle Tarver, initiated a pilot program aimed at speeding up public notifications for high-risk recalls. This pilot included the first-ever early alert for a Fresenius infusion pump recall in November.

Several high-profile devices faced scrutiny in 2024, such as heart pumps from Abiomed and Abbott’s Heartmate devices, the only left ventricular assist devices on the market after Medtronic pulled its alternative in 2021. In addition, the FDA took actions regarding quality issues with plastic syringes from Chinese manufacturers, halting imports from certain suppliers. Other significant recalls included Hologic's Biozorb radiographic markers after adverse event reports, Zimmer’s hip implants due to fracture risks, and J&J’s Megadyne pediatric electrode pads after burn incidents. As the year progressed, the FDA and medical device companies focused on improving the recall process to ensure greater patient safety and timely alerts.