The U.S. Food and Drug Administration (FDA) has announced a significant milestone: the organization is deploying…
Category: US
US / FDA updates on medical device regulation and quality.
FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed…
FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD…
Critical Recall Alert: Baxter Removes Life2000 Ventilator System Over Cybersecurity Risks
The FDA has announced a Class I recall for Baxter’s Life2000 Ventilation System, citing serious potential…
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,…
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…
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…
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…
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…
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…