FDA Alerts

Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett 980 (Pb980) Ventilator Series

Class 1 Recall: GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit

Class 1 Recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect

Class 1 Recall: Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness

Class 1 Recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing

Class 1 Recall: Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results

Class 1 Recall: GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling

Class 1 Recall: Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results

Class 1 Recall: Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes

Class 1 Recall: Alcon Research, LTD. Recalls CyPass Micro-Stent Systems Due to Risk of Endothelial Cell Loss