Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, ...

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...

More than 10 million medical devices were recalled in 2020, according to the Food and Drug Administration1. All medical devices carry some risks, and sometimes either the FDA or the device ...

One percent of the 3000 medical devices approved by the FDA are Class III, high-risk medical devices sustaining or supporting life or capable of “unreasonable risk or illness or injury.” They require ...

The FDA has issued a notice warning of a device correction related to ventilators from Philips Respironics. This marks the ...

Minneapolis-based Smiths Medical recalled nearly 20 million medical devices after two deaths, 25 injuries and 10,672 incidents were reported, the FDA said Feb. 2. In a Class I recall — the most ...

With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

Good morning. I’m David Hilzenrath, a D.C.-based reporter for KFF Health News with an interest in medical product regulation. Had an experience with a medical device that you’d like to share ...

C-Suite Timing of Medical-Device Recalls Linked to CEO’s Ownership Stake in the Company Researchers also found that the longer the delay, the bigger the penalty in the stock market ...

Receiving a recall notice for a medical device can be deeply unsettling for Louisiana residents who rely on these devices daily—whether for sleep support, pain management, or mobility—news of ...