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.
FDA Proposes Ban of Certain ESDs
Ban would affect devices used to treat aggressive/self-injurious behavior In a landmark move, the U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) designed to reduce or stop self-injurious or aggressive behavior. This...
Abbott Safety Alert for Freestyle Libre Systems
Misuse may cause battery overheating and incorrect readings The FDA has issued a safety notification regarding the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The notification warns users of the potential for...
Camber Recalls Atovaquone Oral Suspension USP
Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug...
Exposure to toxic materials during hemodialysis and dialysis
FDA announcement The US Food and Drug Administration (FDA) issued an announcement on March 7 to update its May 2022 letter to healthcare providers regarding the potential risks of exposure to toxic compounds when using hemodialysis and peritoneal dialysis. This update...
FDA Explores Dental Device Safety Concerns
Dental Devices to Treat Sleep Apnea and TMD The FDA is currently evaluating safety concerns related to certain dental devices called fixed (non-removable) palatal expanders, which are used on adults for jaw remodeling or to treat conditions like obstructive sleep...
Update – Carcinoma Inside Capsule of Breast Implants
Squamous Cell Carcinoma and Various Lymphomas Located in the Capsule around Breast Implants On March 22, the US Food and Drug Administration (FDA) issued an update to its March 8 safety communication regarding reports of squamous cell carcinoma (SCC) and lymphomas in...