BEUDAMED
    32 results · 11ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

    FDA Recall
    Open, Classified ·3M Unitek Corporation·Product code KLE·November 26, 2024

    MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; PUMP MMT-1885XC 780G V6.5 CLIN MM; PUMP MMT-1886XC 780G V6.5 CLIN MG; PUMP MMT-1885L MM780G 6.5V BLE MMOL; PUMP MMT-1886L MM780G 6.5W BLE MG; KIT MMT-1896ES MM780G V6.5W MG; KIT MMT-1896WWA MM780G BLE MG ES; KIT MMT-1895WWA MM780G BLE MMOL AR; KIT MMT-1895WWA MM780G BLE MMOL CS; KIT MMT-1895WWA MM780G BLE MMOL DA; KIT MMT-1895WWA MM780G BLE MMOL DE; KIT MMT-1895WWA MM780G BLE MMOL EN; KIT MMT-1895WWA MM780G BLE MMOL FI; KIT MMT-1895WWA MM780G BLE MMOL FR; KIT MMT-1895WWA MM780G BLE MMOL IT; KIT MMT-1895WWA MM780G BLE MMOL NL; KIT MMT-1895WWA MM780G BLE MMOL NO; KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV; KIT MMT-1895WWA MM780G BLE MMOL HU; KIT MMT-1896WWA MM780G BLE MG AR; KIT MMT-1896WWA MM780G BLE MG DE; KIT MMT-1896WWA MM780G BLE MG EL; KIT MMT-1896WWA MM780G BLE MG HE; KIT MMT-1896WWA MM780G BLE MG IT; KIT MMT-1896WWA MM780G BLE MG PL; KIT MMT-1896WWA MM780G BLE MG RO; KIT MMT-1896WWA MM780G BLE MG TR; KIT MMT-1896WWA MM780G BLE MG NL; KIT MMT-1896WWA MM780G BLE MG FR; KIT MMT-1896WWA MM780G BLE MG ES;

    FDA Recall
    Open, Classified ·Medtronic Minimed·Product code OZP·March 15, 2021

    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NIK·August 16, 2023

    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LWS·August 16, 2023

    Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·October 6, 2025

    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·October 6, 2025

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OYC·February 13, 2026

    MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZP·February 13, 2026

    Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code N/A·February 13, 2026

    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OYC·February 13, 2026

    Paradigm Insulin Pump (MMT-712, MMT-715)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code LZG·February 13, 2026

    MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OYC·February 13, 2026

    MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZO·February 13, 2026

    MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code QFG·February 13, 2026

    MiniMed 530G Insulin Pump (MMT-551, MMT-751)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZO·February 13, 2026

    MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZP·February 13, 2026

    MiniMed 620G Insulin Pump (MMT-1750)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OYC·February 13, 2026

    MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OYC·February 13, 2026