FDA Warns Against Unauthorized Infant Monitors: What Parents Need to Know On September 16, 2025, the U.S. Food and Drug Administration (FDA) issued a critical...
FDA Issues Class I Correction for mo-Vis R-net Wheelchair Joysticks Over Dangerous Firmware Error The U.S. Food and Drug Administration (FDA) has issued a Class...
Boston Scientific Issues New Notice on Accolade Pacemaker Software Update Boston Scientific has issued a new notice about its Accolade family of pacemakers, following a...
Early Recalls Raise Concerns About AI-Enabled Medical Devices Artificial intelligence–enabled medical devices (AIMDs) are reshaping U.S. healthcare. They are promising faster diagnoses, improved decision-making, and...
Abiomed’s Impella Recall and the Future of Cardiovascular Device Innovation When the U.S. Food and Drug Administration (FDA) issues a Class I recall, it signals...
Medtronic's Left Heart Vent Catheter Recall: A Wake-Up Call for Medical Device Quality At Ketterer, Browne & Davani (KBD) Attorneys, we closely track issues involving...
FDA Recall Alert: DermaRite Antiseptic Products Contaminated with Burkholderia Cepacia DermaRite Industries Issues Nationwide Recall of Antiseptic Products On August 8, 2025, DermaRite Industries, LLC...
FDA Warns of Weight Loss Risk in Children Under 6 Taking Extended-Release ADHD Medications KBD Attorneys Monitors Drug Safety Updates That Affect Children and Families...
Cook Medical Angiographic Catheter Recall At KBD Attorneys, we regularly investigate product recalls involving medical devices, especially when those products place patients at risk of...
CereLink Intracranial Pressure Monitor Recall – A Critical Medical Device Failure The CereLink Intracranial Pressure (ICP) Monitor, designed to measure brain pressure in critically ill...
