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 ...

AirLife and Vyaire are recalling specific infant breathing support systems due to a potentially dangerous defect that could ...

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 ...

FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I ...

Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration.

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 ...

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 ...

Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The ...

The pilot by the FDA’s CDRH will improve communications about corrective actions being taken over certain medical device recalls.

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the FDA’s medical device approval standards.

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

The analysis comes as regulators investigate how the FDA authorizes medical devices and handles safety recalls.