BEUDAMED
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    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)

    FDA Recall
    Open, Classified ·CUE HEALTH INC·Product code QWB·May 24, 2024

    MAMMOMAT Inspiration;

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code MUE·October 24, 2025

    MAMMOMAT Revelation;

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code MUE·October 24, 2025

    MAMMOMAT Fusion;

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code MUE·October 24, 2025

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code QHE·March 12, 2026

    Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MUE·October 24, 2025

    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France·Product code QHE·June 25, 2021

    Senographe Pristina

    FDA Recall
    Open, Classified ·GE Medical Systems, SCS·Product code MUE·December 26, 2023

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code MUE·April 8, 2026

    Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Recall
    Open, Classified ·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025

    Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.

    FDA Recall
    Open, Classified ·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025

    The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

    FDA Recall
    Open, Classified ·Sophysa Rue Sophie Germain Besancon France·Product code GWM·November 17, 2025

    Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Recall
    Open, Classified ·Clariance-SAS 18 Rue Robespierre Beaurains France·Product code KWQ·February 20, 2026

    Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.

    FDA Recall
    Open, Classified ·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025

    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·May 8, 2018

    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·December 18, 2024

    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025