The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems,…
Category: US
US / FDA updates on medical device regulation and quality.
U.S. Agencies Execute Record Seizure of Unauthorized E-Cigarettes Worth $86.5 Million
The U.S. Department of Health and Human Services (HHS) and U.S. Customs and Border Protection (CBP)…
Critical FDA Warning: Olympus Initiates Recall of ViziShot 2 FLEX (19G) Needles Due to Safety Risks
On August 6, 2025, Olympus issued an urgent recall for specific lots of its ViziShot 2…
FDA Unveils Groundbreaking Dashboard for Real-Time Reporting of Cosmetic Product Adverse Events
On September 30, 2025, the U.S. Food and Drug Administration (FDA) introduced a new interactive tool,…
Essential Tools for Tracking Medical Device Recalls and Alerts
On September 30, 2025, the FDA spotlighted the resources designed to help medical device professionals stay…
FDA Accelerates Approval of Forzinity: A Milestone for Barth Syndrome Treatment
The U.S. Food and Drug Administration (FDA) has taken a groundbreaking step by granting accelerated approval…
FDA Expands Early Alert Program for High-Risk Medical Device Recalls
On September 29, 2025, the FDA announced the expansion of its Early Alert program. This initiative…
Critical FDA Advisory: Updated Performance Alerts for BD Alaris Infusion Sets
An updated communication from the FDA highlights significant concerns regarding BD Alaris Infusion Sets’ performance under…
FDA Expands Access to Treatment Addressing Neurological Challenges in Autism
Meta description: The FDA has initiated approval for leucovorin calcium tablets to assist patients with cerebral…
Understanding Medical Device Recalls: What Healthcare Professionals Need to Know
Medical device recalls are critical actions taken to address potential safety or regulatory violations associated with…