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    HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code CGA·April 24, 2025

    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.

    FDA Recall
    Open, Classified ·Reflexion Medical, Inc.·Product code QVA·April 16, 2024

    RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.

    FDA Recall
    Open, Classified ·Reflexion Medical, Inc.·Product code QVA·July 22, 2025

    Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

    FDA Recall
    Open, Classified ·Inter-Med Llc·Product code MVL·May 27, 2026

    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

    FDA Recall
    Open, Classified ·Reflexion Medical, Inc.·Product code QVA·February 9, 2026

    One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

    FDA Recall
    Open, Classified ·Home Health US, Incorporated·Product code QRL·July 25, 2025