The recalled waffles were sold at Costco warehouses in the Midwest between July 15 and August 25, Kodiak said in its letter. The FDA notice shows the waffles were distributed to Iowa, Illinois, ...

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

According to the U.S. Food and Drug Administration (FDA), Authentik Fudge of Sainte-Julie, Quebec, Canada, is recalling 840 ...

The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement ...

Reuters.com is your online source for the latest news stories and current events, ensuring our readers up to date with any ...

The update stated that the implant’s cobalt-chromium alloy carries an increased risk of femur fractures following a procedure ...

Eagle Produce LLC Scottsdale, Arizona is initiating a recall of 224 cases of whole cantaloupe because they have the potential ...

Short follow-up is another problem that often appears in the backstory of recalled cardiovascular devices, such as the ...

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

The majority of FDA-recalled devices made it to market via the 510(k) pathway, which doesn’t require new clinical or safety ...