BEUDAMED
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    Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

    FDA Recall
    Open, Classified ·Datex-Ohmeda Inc·Product code FMT·May 8, 2026

    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

    Change Healthcare Radiology Solutions software version 14.2.2

    FDA Recall
    Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code LLZ·August 13, 2025

    smiths medical Medfusion Model 4000 syringe pump

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DRE·March 27, 2025

    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DRE·August 12, 2024

    CURAD REUSABLE GEL HOT/COLD PACK

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code IME·December 15, 2021

    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022