The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the ...

According to the U.S. Food and Drug Administration records, in an average year over 2,500 medical device recalls are issued in the United States. Some of these recalls simply require checking the ...

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially ...

The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find. With this in mind, a new Boston-based startup called Soom is aiming to target this ...

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 ...

Three separate federal agencies have each been adding recall records to their databases at a steady clip through the first half of 2026, and the combined count now stretches past 300 individual ...

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 ...

Medtech recalls get a bad rap, but these regulatory actions are not always a bad thing. Take, for instance, InspireMD’s recent voluntary recall for its CGuard Prime 135 cm carotid stent delivery ...