Medical Devices

2015 Medical Device Recalls

The list below contains recalls that were issued in 2015.

2015 Recalls

Device NameDate
bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error 12/29/15
Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure 12/23/15
Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin 12/23/15
Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working 12/23/15
eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm 12/07/15
Boston Scientific’s RotaWire Elite Guidewire and wireClip Torquer Guidewire May Break and Separate from the Rotablator System 11/27/15
Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure 11/13/15
MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 10/02/15
SynCardia Systems, Freedom Driver System - Part May Fail Causing Device to Stop Working 09/18/15
Insulet Corporation OmniPod Insulin Management System May Fail to Deliver Insulin 09/10/15
Covidien, Puritan Bennett 980 Ventilators - Amount of Air Delivered May Be Lower Than Programmed 09/02/15
Dräger Medical, Evita V500 and Babylog VN500 Ventilators - Faulty Batteries 09/02/15
CareFusion Alaris Syringe Pump Alarm Error May Cause Interruption of Therapy 08/27/15
Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane, Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump 08/27/15
Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube - Connector May Crack or Separate 08/26/15
Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst 08/18/15
Cook Medical, Beacon Tip Angiographic Catheters, Catheter Tip May Split or Separate 08/07/15
Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes: Switching Tubes May Cause Breathing Issues 07/15/15
Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator Intake Port Blockage 07/02/15
FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation 07/01/15
Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues 06/19/15
HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls 06/19/15
Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch - May Cause Blood Clots 06/05/15
LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits - Not Cleared for Marketing 04/23/15
Maquet Medical Systems, Tiger Paw System II - May Cause Tears and Bleeding in Heart Tissue 03/25/15
Hospira Plum A+ and Plum A+3 Infusion Systems Alarm Volume Failure 03/05/15
HeartWare Ventricular Assist System (VAS) – Electrostatic Discharge May Cause Pump Failure 02/27/15
Teleflex Medical, MAQUET Servo Humidifier 163 - Cracks in Connector Tubes May Lead to Leak Failures 02/25/15
Teleflex Medical, MAQUET Servo Humidifier 163 - Connector Cracks May Lead to Leak Failure 02/25/15
GE Healthcare Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit 02/25/15
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue 02/10/15
Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) - Falsely Low INR Test Results 01/08/15

Page Last Updated: 01/05/2016
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