FDA Warns Against Imported Cookware Linked to Dangerous Lead Contamination
The U.S. Food and Drug Administration (FDA) has issued a critical update urging both retailers and consumers to stop selling…
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US / FDA updates on medical device regulation and quality.
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FDA Introduces Green List to Prevent Unsafe GLP-1 Drug Imports
The U.S. Food and Drug Administration (FDA) has launched a significant regulatory measure aimed at curbing the entry of illegal…
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FDA Signals Urgent Catheter Packaging Defect: Abbott’s Updated Guidance for TactiFlex Ablation Users
The FDA has recently issued an early alert highlighting a critical concern with Abbott’s TactiFlex Ablation Catheter, Sensor Enabled. This…
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FDA Greenlights Expanded Pediatric and Adult Use of Vonvendi for von Willebrand Disease
The U.S. Food and Drug Administration (FDA) has announced its approval for the expanded use of Vonvendi, also known as…
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Voluntary Recall Issued for Olympus ViziShot 2 FLEX 19G Needles Due to Safety Concerns
Olympus Corporation has announced a voluntary global recall of specific lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. These…
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FDA Targets Misleading Drug Ads with New Compliance Initiative
The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have announced major regulatory…
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FDA Highlights Safety Alert for Abiomed’s Impella Controllers Due to Purge Retainer Issue
The FDA has issued an early alert regarding a significant safety concern with Abiomed’s Automated Impella Controllers. Clinical, quality, and…
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FDA Launches Guidance to Advance Non-Opioid Chronic Pain Solutions and Battle Opioid Misuse
The U.S. Food and Drug Administration (FDA) has announced a major step in addressing the opioid crisis by releasing draft…
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Critical Update: 3M Issues Urgent Labeling Correction for Ranger Blood and Fluid Warming Systems
The 3M Company has announced a critical correction for its Ranger Blood and Fluid Warming Systems, following discrepancies between labeled…
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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) announced on September 30,…
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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 FLEX (19G) Endobronchial Ultrasound…
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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, the FDA Adverse Event…
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