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    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DQX·March 27, 2025

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Recall
    Open, Classified ·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024

    DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

    VADER pedicle system, torque wrench, Catalog Number 42-703

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

    VADER pedicle system, torque wrench, Catalog Number 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    FDA Recall
    Terminated ·Coltene Whaledent AG Feldwiesenstrasse 20 Altstatten Sg Switzerland·Product code EJL·July 19, 2019

    Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System

    FDA Recall
    Terminated ·Advanced Bionics Corporation·Product code LGW·November 11, 2004

    Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LGW·February 27, 2014

    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 3, 2022

    Model A710 Intellis Clinician Programmer Application, version 2.0.97

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 19, 2023

    Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LGW·May 16, 2024

    Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.

    FDA Recall
    Terminated ·St. Jude Medical, Inc.·Product code LGW·June 2, 2017

    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701), PrimeAdvanced (37702), Spinal Cord Stimulators for chronic pain.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LGW·February 27, 2014

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Vanta Implantable Neurostimulator (INS), Model 977006

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·August 21, 2024

    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

    FDA Recall
    Terminated ·Boston Scientific Neuromodulation Corporation·Product code LGW·April 24, 2019

    GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.

    FDA Recall
    Terminated ·Greer Laboratories, Inc.·Product code DGW·October 25, 2022

    Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

    FDA Recall
    Terminated ·Medtronic Neurological·Product code LGW·August 2, 2006

    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LGW·September 30, 2013