BEUDAMED
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    MONARCH Bronchoscope. Model Number: MBR-000211-B

    FDA Recall
    Open, Classified ·Auris Health, Inc·Product code QNW·October 18, 2025

    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·March 9, 2021

    VITEK 2 Systems and VITEK 2 with MYLA.

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LON·March 29, 2022

    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWA·March 3, 2021

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022

    Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·March 25, 2021

    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.

    FDA Recall
    Open, Classified ·Medtronic Inc·Product code NPV·March 2, 2022

    NIM TRIVANTAGE EMG Endotracheal Tube

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·December 22, 2021

    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·February 28, 2022

    VenaSeal Closure System

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code PJQ·March 23, 2021

    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

    FDA Recall
    Open, Classified ·Medtronic Inc·Product code DSQ·March 30, 2022

    Oncentra Brachy radiation therapy planning system software.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code MUJ·December 5, 2022

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 9, 2023

    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 9, 2023

    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Instructions For Use (FI) HVAD System Instructions For Use (FI) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Instructions For Use - FI HVAD System Instructions For Use (FI) HVAD System OUS Patient Manual (FI-Finnish) HVAD System Emergency Responder Guide (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System OUS Instructions For Use (TR-Turkish)

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·March 30, 2022