In the United States, the device is being used under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). Findings from the WAVE ... the rights of other parties; ...
As someone that has been covering recalls for EatingWell since 2022, I will say recalls are more common than you may think.
The FDA and manufacturers routinely allow doctors and hospitals to continue using medical devices that could cause serious ...
The maker of a homeopathic nasal spray with a history of contamination is refusing to recall its product after the Food and ...
FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...
A recall has been issued for a number of snacks sold across the country over concerns of undeclared ingredients and allergen ...
Dairy company HP Hood has voluntarily recalled Lactaid, a lactose-free dairy milk, in 27 states due to potential exposure of an allergen, according to the company and the Food and Drug ...
The products were voluntarily recalled "due to the potential presence of soft plastic film," leading them to be given a Class II risk level.
The update stated that the implant’s cobalt-chromium alloy carries an increased risk of femur fractures following a procedure ...
Good morning. I’m David Hilzenrath, a D.C.-based reporter for KFF Health News with an interest in medical product regulation. Had an experience with a medical device that you’d like to share?
The FDA designated the ReviveRX recall a class I — the most serious level, meaning that “there is a reasonable probability that the use of or exposure to a violative product will cause serious ...