FDA Alerts
Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett 980 (Pb980) Ventilator Series
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: GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling
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: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing
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: Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results
Class 1 Recall: Alcon Research, LTD. Recalls CyPass Micro-Stent Systems Due to Risk of Endothelial Cell Loss
Class 1 Recall: Pro-Med Instruments Recalls the DORO LUCENT Headrest Due to Possible Malfunction and Failure