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    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

    FDA Recall
    Open, Classified ·Powers Medical Devices, LLC·Product code HCC·October 1, 2015

    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

    FDA Enforcement
    Class II ·Ongoing·Powers Medical Devices, LLC·December 16, 2015

    NIMBUS J AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·INFUTRONIX, LLC·Product code FRN·November 27, 2023

    ITOVI TRACKER/SCANNER

    FDA Adverse Event
    Injury ·ITOVI·Product code GZO·July 9, 2018

    SALTER AIRE ELITE

    FDA Adverse Event
    Malfunction ·SALTER LABS DE MEXICO DE S.A. DE C.V.·Product code CCQ·October 15, 2025

    NIMBUS II FLEX AMBULATORY INFUSION PUMP

    FDA Adverse Event
    Malfunction ·INFUTROINX, LLC·Product code FRN·November 27, 2023

    POWERLED

    FDA Adverse Event
    Injury ·MAQUET SAS·Product code FSY·April 30, 2018

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 15, 2016

    FREESTYLE HANDS-FREE BREASTPUMP

    FDA Adverse Event
    Injury ·MEDELA AG·Product code HGX·October 3, 2017

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·January 31, 2025

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·April 30, 2025

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·September 26, 2025

    MEDIFROST

    FDA Adverse Event
    Malfunction ·CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD·Product code ILO·May 14, 2025

    SONATA DELUXE DOUBLE ELECTRIC BREASTPUMP SINGLE CAN

    FDA Adverse Event
    Injury ·MEDELA LLC·Product code HGX·December 12, 2019

    NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·November 10, 2023

    NEXUS® ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·June 16, 2023

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·April 4, 2025

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    FDA Adverse Event
    Malfunction ·MEDELA LLC·Product code HGX·March 13, 2019

    INVIA MOTION+ ENDURE SINGLE

    FDA Adverse Event
    Malfunction ·MEDELA AG·Product code OMP·April 8, 2019

    NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·November 21, 2024