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    Filters FDA Recall × Status: Open, Classified × Clear all

    Percept BrainSense Implantable Neurostimulator (INS), Model B35200

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·March 30, 2022

    A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·May 15, 2024

    Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·May 13, 2026

    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

    Clinician Programmer Application (CPA) model A610 Clinician Software Application

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·September 23, 2021

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

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

    SenSight Connector Plug, Model Number B31061.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·January 20, 2023

    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·May 22, 2024

    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·September 24, 2024

    Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·May 13, 2026

    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·May 22, 2024

    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·March 17, 2023

    Parasite Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code MHI·November 3, 2025

    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

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

    Model B35200 - Percept PC BrainSense Implantable Neurostimulator

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·October 19, 2021

    Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code MHY·November 4, 2021

    Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·May 22, 2024

    Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only

    FDA Recall
    Open, Classified ·Abbott Medical·Product code MHY·May 22, 2024

    Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MHI·March 24, 2025

    Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFC·April 21, 2026