This article originally appeared on ProPublica. The Food and Drug Administration rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it’s sometimes ...

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

Notable medtech companies including Dexcom, Abbott, and Medtronic, have earned themselves a spot on FDA's December recalls list.

Illinois Sen. Dick Durbin and Rep. Jan Schakowsky want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators to improve what they ...

ICU Medical is recalling its IV Gravity Burette Set which could cause serious injury or even death, according to U.S. health regulators. The IV Gravity Burette Set is a medical device used to give ...

The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical found that scrapings of ...

This story was originally published by ProPublica. The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's sometimes unable to make sure ...