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    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 28, 2024

    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code LOM·November 1, 2018

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Recall
    Open, Classified ·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025

    MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZP·November 2, 2025

    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KPN·September 30, 2022

    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KPN·September 30, 2022

    Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KPN·September 30, 2022

    Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KPN·September 30, 2022

    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MOI·July 18, 2022

    VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001

    FDA Recall
    Open, Classified ·Ventana Medical Systems, Inc.·Product code PLS·November 18, 2022

    Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742

    FDA Recall
    Open, Classified ·Medtronic MiniMed·Product code OZP·September 20, 2022

    Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752

    FDA Recall
    Open, Classified ·Medtronic MiniMed·Product code OYC·September 20, 2022

    Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B100292, P7900B100296, P7900B100302, P7900B100303, P7900B100304, P7900B100305, P7900B100312, P7900B100316, P7900B100318, P7900B100335, P7900B100341, P7900B100342, P7900B100354, P7900B100361, P7900B100368, P7900B100372, P7900B100381, P7900B100382, P7900B100384, P7900B100385, P7900B100387, P7900B100388, P7900B100392, P7900B100395, P7900B100396, P7900B100407, P7900B100408, P7900B100438, P7900B100441, P7900B1PL270, P7900B1PLT71, P7900B1SPL05, P7900B200193, P7900B200195, P7900B200230, P7900B200236, P7900B200264, P7900B200268, P7900B200292, P7900B200302, P7900B200318, P7900B200342, P7900B200361, P7900B200372, P7900B200381, P7900B200382, P7900B200392, P7900B200395, P7900B200396, P7900B200408, P7900B200439, P7900B200441, P7900B200443, P7900B200445, P7900B200452, P7900B200453, P7900B200464, P7900B200485, P7900B2SPL12, P7900B300441, P7900B300453, P7900B300518

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FNL·September 30, 2022

    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Recall
    Open, Classified ·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025

    Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Recall
    Open, Classified ·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025