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 ...

Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most serious type of recall. There were 1,048 medical device recalls in 2024 ...

All medical devices carry some risks, and sometimes either the FDA or the device manufacturer determines that those risks outweigh benefits and issues a recall notice. When recalling a device ...

The truth is, a recall notice is rarely the end of the story. Instead, it marks the beginning of a longer, more personal ...

Fewer medical devices were recalled during the first three months of the year, following a surge in recalls in 2024. In the first quarter of 2025, there were 708 medical device recalls ...

Guillermo Ramas started the software company NotiSphere to fix our broken medical recall system. He spoke with Fast Company about how it works. The current state of medical device recalls is ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or ...

The U.S. Food and Drug Administration on Tuesday announced a Class 1 recall — the most serious level — affecting more than 26,000 Medtronic devices used to treat brain aneurysms. The recall ...

Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter ...