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...
Artificial intelligence–enabled medical devices (AIMDs) are reshaping U.S. healthcare. They are promising faster diagnoses, improved decision-making, and expanded patient access to advanced technologies. But with...
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...
At Ketterer, Browne & Davani (KBD) Attorneys, we closely track issues involving medical device safety and accountability. In fact, we have written about Medtronic before,...
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...
KBD Attorneys Monitors Drug Safety Updates That Affect Children and Families Source: FDA Drug Safety Communication – July 2025 At KBD Attorneys, we believe protecting...
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...
