BEUDAMED
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    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Recall
    Open, Classified ·Hycor Biomedical Inc·Product code DHR·March 19, 2018

    1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    SIGNA Excite 3T. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code LNH·February 18, 2022

    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·June 5, 2023

    Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code HKO·February 18, 2026

    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024

    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code QMN·January 3, 2024

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Recall
    Open, Classified ·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020

    FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code NSU·October 17, 2023

    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·April 21, 2023

    Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,

    FDA Recall
    Open, Classified ·Masimo Corporation·Product code DQA·February 15, 2024

    Medline Leg bag, REF DYND12578

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FAQ·October 19, 2023

    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

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

    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023