BEUDAMED
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    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    FDA Recall
    Open, Classified ·Intersect ENT, Inc.·Product code OWO·October 21, 2022

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·March 4, 2022

    OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

    FDA Recall
    Open, Classified ·SIMPLIVIA HEALTHCARE LTD. NORTH IND. ZONE, (MIGADA PLANT) NORTH IND. ZONE PoBOX·Product code ONB·March 8, 2022

    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

    FDA Recall
    Open, Classified ·Draeger Medical Systems, Inc.·Product code MHX·May 13, 2024

    Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019

    Ellume COVID-19 Home Test

    FDA Recall
    Open, Classified ·ELLUME LTD 57 Didsbury St East Brisbane Australia·Product code QKP·October 1, 2021

    Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019

    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·October 9, 2019

    Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code CBK·September 10, 2021

    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code NGT·August 19, 2021

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code CBK·September 10, 2021

    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·September 13, 2019

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger Medical, Inc.·Product code BSZ·October 15, 2024

    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·September 9, 2025

    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code BSZ·September 9, 2025

    Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

    FDA Recall
    Open, Classified ·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023

    Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

    FDA Recall
    Open, Classified ·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023

    Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·November 1, 2022