BEUDAMED
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    Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    FDA Recall
    Open, Classified ·Steris Corporation·Product code KQM·May 23, 2025

    MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display

    FDA Recall
    Completed ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·April 24, 2024

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    FDA Recall
    Open, Classified ·Product code DXJ·July 27, 2022

    Barco MDSC-8527 NXF, Part Number K9352421

    FDA Recall
    Open, Classified ·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code KQM·December 20, 2023

    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FMI·July 10, 2017

    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code OLO·April 11, 2014

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Recall
    Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code KKX·July 19, 2013

    Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code HSX·June 4, 2014

    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code HSX·June 4, 2014

    ORAcollect RNA: ORE-100

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Recall
    Terminated ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020

    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code OYJ·February 18, 2022

    Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

    Stryker PainPump1 Base Kit; Product number 500-100-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006

    LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

    FDA Recall
    Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

    CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2112-0300-01; 5) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA, Model Number: 21-2111-0300-01; 6) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-51; 7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-51; 9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, CE ENGLISH 1/EA, Model Number: 21-2111-0400-51; 11) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2111-0300-50; 12) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 13) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 14) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-78; 15) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 16) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2112-0300-00; 17) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-78; 18) PUMP, DEMO, CADD-SOLIS, MODEL 2100, NOT FOR HUMAN USE 1/EA, Model Number: 21-2101-249; 19) PUMP KIT, CADD-SOLIS, MDL 2110, TRIAL/LOANER, V4.1, CE ENGLISH 1/EA, Model Number: 21-2111-0401-78; 20) PUMP KIT, CADD-SOLIS, YELLOW, MDL 2100 1/EA, Model Number: 21-2102-51; 21) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, NFHU, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-249; 22) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA, Model Number: 21-2111-0300-231; 23) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1, TRIAL/LOANER YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0401-78; 24) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0400-51; 25) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA, Model Number: 21-2112-0300-50; 26) PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA, Model Number: 21-2111-0300-00; 27) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2110 1/EA, Model Number: 21-2111-0100-00; 28) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH 1/EA, Model Number: 21-2111-0100-51; 29) PUMP, CADD-SOLIS, MODEL 2110, CE ENGLISH OUS 1/EA, Model Number: 21-2111-0100-50; 30) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH 1/EA, Model Number: 21-2101-51; 31) PUMP KIT, CADD-SOLIS HPCA, YELLOW KEYPAD, MODEL 2110, CE ENGLISH, OUS 1/EA, Model Number: 21-2112-0100-50; 32) PUMP, TRIAL/LOANER, CADD- SOLIS, MODEL 2100 1/EA, Model Number: 21-2101-00; 33) PUMP KIT, CADD-SOLIS, MDL 2110, v4.0, YELLOW, ENGLISH 1/EA, Model Number: 21-2112-0400-01.

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code MEA·April 10, 2025

    Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

    Stryker PainPump1.5 2-Day Infusion Kit; Product number 501-140-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006