Safety Alerts
The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices, pharmaceuticals, biologics, vaccines, dietary supplements, and cosmetics.
The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on its MedWatch program.
When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints, or other factors, it will issue a warning or safety alert to health care providers and the public.
Warnings and safety alerts can include:
- Product issues.
- Ancillary issues that can be a safety hazard, such as labeling.
- Recalls.
- Any other information related to a negative effect on the safety of a product.
Medical Devices and Pharma is focused on providing consumer information regarding medical devices and pharma, and we will report warnings and safety alerts for those products and any that are directly related to their safety.
Class I Recall for Intra-Aortic Blood Pumps
Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced yesterday...
Urgent Action Required – Baxter LIFE2000 System
Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced that...
FDA Posts Warning Letter to MicroVention Costa Rica
Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to...
FDA Issues Letter to Warn of Abbott Trifecta Valve Risks
Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare providers...
FDA Announces Recall of GE Nuclear Medicine Systems
1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain nuclear...
FDA announces recall of LivaNova LifeSPARC System
The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical...