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.
Device Recall: ZOLL AutoPulse NXT Resuscitation System
Urgent Class I Medical Device Recall ZOLL Circulation, Inc. has issued a Class I recall of its AutoPulse NXT Resuscitation...
Alert: Ventilator Systems Risk in Neonatal Tidal Volume Delivery
Maquet Servo Ventilator SystemsSource: FDAUrgent Class I Medical Device Correction Maquet Critical Care AB, a subsidiary of...
Urgent Recall of Codman Disposable Perforators
Urgent Class I Medical Device Recall Integra LifeSciences has issued an urgent recall of specific Codman Disposable...
FDA Cracks Down on Insightra Medical
Warning Letter Cites a Number of Serious Violations In a scathing warning letter, the FDA has cited Insightra Medical, Inc....
FDA Cracks Down on Illegally Marketed 7-OH Products
Unapproved drugs sold online and in retail locations Yesterday the U.S. Food and Drug Administration (FDA) issued seven...
Sterile Drug Manufacturing Violations at Daewoo Pharmaceutical
FDA Cracks Down on Sterile Drug Manufacturing Violations The U.S. Food and Drug Administration (FDA) has issued a warning...