BEUDAMED
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    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No

    FDA Recall
    Open, Classified ·Edan Diagnostics·Product code DQA·October 24, 2025

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·February 15, 2024

    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.

    FDA Recall
    Terminated ·Combat Medical Systems, LLC·Product code POQ·December 23, 2020

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code BWB·February 23, 2024

    Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWB·August 29, 2011

    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.

    FDA Recall
    Terminated ·Sony Medical Systems·Product code FWB·January 13, 2015

    Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FWB·December 15, 2017

    Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWB·October 21, 2011