Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience…
Category: US
US / FDA updates on medical device regulation and quality.
Critical Alert: FDA Revises Usage Guidelines for B Braun Hemodialysis Blood Tubing Set
The U.S. Food and Drug Administration has issued an urgent notice regarding the updated instructions for…
Critical Safety Update: NOxBOXi Nitric Oxide Delivery System Correction for Rapid Command Input Issue
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has announced a critical correction for…
Attention Clinicians: NOxBOX Ltd. Issues Critical Update for NOxBOXi Nitric Oxide Delivery System Over Dosing Concerns
NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., has issued a vital correction for…
Siemens Healthineers Corrects Critical Safety Issue with 3 Tesla MRI Systems
Siemens Healthineers has announced corrective actions for its 3 Tesla MRI systems, addressing a potentially severe…
Critical FDA Alert: Sterile Medline Convenience Kits Recalled Due to Non-Sterilization
Healthcare professionals and supply managers, please be aware of an urgent recall announced by Medline Industries,…
FDA Launches New Program to Accelerate Meeting Minutes Clarifications
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program aimed at enhancing…
FDA Adds High-Profile Warning to Elevidys Label Amid Fatal Liver Injury Reports
The U.S. Food and Drug Administration (FDA) has approved a significant update to the labeling of…
FDA Issues Guidance on Unauthorized Anti-Choking Devices: Follow Proven Rescue Protocols
The Food and Drug Administration (FDA) has issued an important update encouraging the public to use…
FDA Announces Appointment of Richard Pazdur as New CDER Director
The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert…