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    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

    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code LQR·March 5, 2026

    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Recall
    Open, Classified ·Edwards Lifesciences, LLC·Product code DQR·May 14, 2025

    COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code LQR·March 5, 2026

    VITEK 2 Systems and VITEK 2 with MYLA.

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

    MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).

    FDA Recall
    Open, Classified ·Avanos Medical, Inc.·Product code KNT·May 31, 2024

    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