FDA Issues Urgent Recall of Mega Ballast Medical Devices Due to Serious Health Risks
The FDA has flagged a critical recall concerning Balt USA’s Mega Ballast Distal Access Platform devices, identified as carrying a…
US
US / FDA updates on medical device regulation and quality.
168 articles
168 articles in US
Latest News
Latest News
FDA Warns About Potential Reverse Flow Issue in Fresenius Kabi Large Volume Pump Sets
The FDA has issued an Early Alert regarding a potential high-risk issue with certain Fresenius Kabi Ivenix Large Volume Pump…
Latest News
Urgent Recall of SpeedControl Dials for SmartDrive MX2+ Power Assist Devices Due to Safety Hazards
Max Mobility/Permobil has initiated an urgent recall of SpeedControl Dials used in their SmartDrive MX2+ Power Assist Devices. This action…
Latest News
Supreme Deli LLC Recalls Boar’s Head Pecorino Romano Cheese Over Listeria Risks
Supreme Deli LLC, conducting business as Supreme Service Solutions, has announced a voluntary recall of specific Boar’s Head Pecorino Romano…
Latest News
FDA Grants Approval for Gene Therapy Addressing Spinal Muscular Atrophy Treatment Needs
The U.S. Food and Drug Administration (FDA) has officially approved Itvisma (onasemnogene abeparvovec-brve), a gene therapy developed for patients with…
Latest News
FDA Issues Critical Recall Alert for Intersurgical i-View Video Laryngoscopes
On November 22, 2025, the FDA released details regarding a significant recall of the i-View Video Laryngoscope, manufactured by Intersurgical…
Latest News
Critical Update: Revised Instructions for Flexicare BritePro Solo Devices in Medline Kits
Medline Industries, LP has issued an urgent revision to the use instructions for Medline medical convenience kits containing the Flexicare…
Latest News
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 the use of the…
Latest News
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 its NOxBOXi Nitric Oxide…
Latest News
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 its NOxBOXi Nitric Oxide…
Latest News
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 safety risk that may…
Latest News
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, LP. The company is…
Loading more articles…