72019Jan
Happy New Year – Here’s a list of Medical Device Recalls from 2018.
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