GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit 12/12/18 Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect 11/27/18 Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness 11/26/18 Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing 11/23/18 Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results 11/20/18 GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling 11/15/18 Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results 11/01/18 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 11/01/18 Alcon Research, LTD. Recalls CyPass® Micro-Stent Systems Due to Risk of Endothelial Cell Loss 10/24/18 Endologix, Inc. Recalls AFX Endovascular AAA Systems Due to Risk of Type III Endoleaks 10/15/18 Pro-Med Instruments Recalls the DORO LUCENT Headrest Due to Possible Malfunction and Failure 09/28/18 Ventana Medical Systems Recalls Multiple Detection Kits Due to Potential for False Negative Results Caused by Reagent Dispenser Issues 09/28/18 Vyaire Medical, Inc. Recalls Tri-Flo Subglottic Suction System Due to Risk of Device Breakage 09/04/18 Compass Health Brands Recalls CPAP Mask Cushion Devices Due to Possible Air Leaks 08/31/18 BioMerieux Recalls VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards Due to False Results for some strains of methicillin-resistant Staphylococcus aureus (MRSA) 08/23/18 Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle 08/10/18 Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery 08/10/18 Qiagen Sciences LLC. Recalls the AmniSure ROM Test Due to Lack of Control Line – Which May Lead to Misinterpretation of Test Results 08/08/18 Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values 06/22/18 Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy 06/06/18 Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller 06/01/18 Abbott Recalls the HeartMate 3™ Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion 05/22/18 Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use 05/18/18 Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design 05/11/18 Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error 05/09/18 Terumo Recalls Sarns™ TCM and TCM II Cooling and Heating Systems and HX2™ Temperature Management Systems Due to Revised Cleaning Instructions 05/07/18 Becton Dickinson (BD) and Company Recalls Vacutainer® EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests 03/23/18 Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes 03/22/18 Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery 02/26/18 Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error 01/30/18 Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow 01/11/18 Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due to improper seal of the sheath hub 01/02/18
