Medical devices are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: Integra LifeSciences has ...

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

Most medical devices developed in the U.S. reach the market through the 510(k) pathway, in which manufacturers prove that technology in their device is "substantially equivalent" to one or more ...

Recalled medical devices can remain on shelves for months, sometimes with deadly results. A software startup called NotiSphere says it has devised a better system.

Becton Dickinson’s recall applies to 17 versions of reusable metal containers under the Genesis Sterrad brand after potential breaches were found.

When it comes to medical devices, recalls can include not only “removals,” but also “corrections,” which address the problem in the field.

The FDA and manufacturers routinely allow doctors and hospitals to continue using medical devices that could cause serious harm or death.

Meeting Coverage > STS Limbo of Cardiac Device Recalls Has Physicians Ready for Change — How innovation may play out under Trump, and medicolegal implications of using recalled devices by Nicole ...

My firm’s recent 2024 Recall Report further suggests an alarming disconnect between consumer concerns about medical product safety and their actions when faced with recalls. We found that just ...

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 death ...

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.

The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use When it comes to medical devices, recalls can include not only “removals,” in which the device is removed ...