The FDA has issued an early alert regarding a potentially high-risk device issue with the Broselow…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Issues Urgent Recall of Draeger Vapor 2000 and Vapor 3000 Anesthetic Vaporizers
The US Food and Drug Administration (FDA) has announced an urgent recall of certain Draeger Vapor…
Olympus Expands Voluntary Recall of ViziShot 2 FLEX EBUS-TBNA Needles Due to Device Component Ejection
Olympus Corporation has expanded its voluntary recall of the ViziShot 2 FLEX (19G) EBUS-TBNA needles due…
FDA Issues Urgent Recall of Medline Anesthesia Kits Due to Potential for Serious Injury or Death
On January 17, 2026, the FDA announced an urgent recall of certain Medline anesthesia kits due…
FDA Issues Early Alert for Boston Scientific’s Stent and Electrocautery-Enhanced Delivery System
As of January 22, 2026, the FDA has issued an early alert regarding a potentially high-risk…
FDA Issues Early Alert for Olympus Insufflation Units Due to Potential Overpressure Risks
An important medical device safety announcement was made on January 26, 2026, regarding certain Olympus insufflation…
FDA Issues Early Alert for Integra LifeSciences’ Wound and Burn Dressing Products
As of January 23, 2026, the FDA has issued an early alert regarding a potentially high-risk…
FDA Initiates Steps to Enhance Gluten Disclosure in Food Products
Meta description: FDA improves gluten ingredient disclosure in foods. Published on 2026-01-26. The US Food and…
FDA ImportShield Program Shows Promising Results in Enhancing Oversight at US Ports of Entry
The US Food and Drug Administration has announced the initial review of the FDA ImportShield Program…
Abbott Issues Important Medical Device Correction for FreeStyle Libre 3 and Libre 3 Plus Sensors in the U.S.
Abbott is addressing a critical issue affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus…