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    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Recall
    Terminated ·Surgical Specialties Mexico S DE RL DE CV Corredor Tijuana Rosarito 2000-24702 B Ejido Francisco Villa Tijuana Mexico·Product code OMT·September 24, 2016

    Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·February 16, 2017

    8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DYB·April 14, 2009

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code CCL·May 23, 2014

    Recreo Hair Growth Laser Comb

    FDA Recall
    Open, Classified ·OMM Imports, Inc. dba Zero Gravity·Product code OAP·September 1, 2022

    VariSoft Infusion Set, Single Use.

    FDA Recall
    Open, Classified ·Unomedical A/S Osted Aholmvej 1·Product code FPA·July 23, 2024

    Neria Soft Infusion Set, Product Code 507302, intravascular administration set

    FDA Recall
    Open, Classified ·Unomedical A/S Osted Aholmvej 1·Product code FPA·March 5, 2024

    Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Recall
    Terminated ·GE Healthcare·Product code FMT·April 2, 2014

    Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Recall
    Terminated ·GE Healthcare·Product code FMT·April 2, 2014

    Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code FMT·July 29, 2009

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code FMT·March 15, 2019

    GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10) M1112198-01084972; 11) M1112198-01090848; 12) M1112198-01093457; 13) M1112198-01117766; 14) M1112198-01139893; 15) M1112198-01156745; 16) M1112198-01167230; 17) M1112198-01177090; 18) M1112198-01183599; 19) M1112198-01185372; 20) M1112198-01193801; 21) M1112198-01200764; 22) M1112198-01245548; 23) M1112198-01253742; 24) M1112198-01274059. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Recall
    Open, Classified ·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMT·August 9, 2024

    GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Recall
    Open, Classified ·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMT·August 9, 2024

    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

    FDA Recall
    Terminated ·GE Healthcare·Product code FMT·April 2, 2014

    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code FMT·March 15, 2019

    Panda Wall Mount warmer. Infant radiant warmer

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code FMT·September 25, 2018