BEUDAMED
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    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·July 25, 2023

    IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438

    FDA Recall
    Open, Classified ·IVOCLAR VIVADENT AG BEDERSRASSE LIECHTSTEIN Germany·Product code EIH·April 5, 2024

    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

    FDA Recall
    Open, Classified ·Schiller, Ag Altgasse 68 Baar Switzerland·Product code DPS·July 24, 2024

    VADER pedicle system, torque wrench, Catalog Number 42-703

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code NKB·November 3, 2022

    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Recall
    Open, Classified ·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026

    Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

    FDA Recall
    Open, Classified ·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·April 24, 2026

    impression coping, repositionable, short, screw-retained, PF 4.0

    FDA Recall
    Open, Classified ·Thommen Medical AG Eschenweg 3 Bettlach Switzerland·Product code NDP·January 24, 2024

    VADER pedicle system, torque wrench, Catalog Number 42-702

    FDA Recall
    Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

    FDA Recall
    Open, Classified ·Medartis AG Hochbergerstrasse 60e Basel Town Switzerland·Product code HWC·January 9, 2026

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code QCB·January 21, 2026

    Ventilator HAMILTON-C6, PN: 160021

    FDA Recall
    Open, Classified ·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·May 15, 2024

    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

    FDA Recall
    Open, Classified ·Maquet Cardiopulmonary Ag Kehler Str. 31 Rastatt Germany·Product code DTQ·April 30, 2025

    Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

    FDA Recall
    Open, Classified ·Hamilton Medical AG via Crusch 8 Bonaduz Switzerland·Product code CBK·March 12, 2018

    HAMILTON-C6, REF: 160021

    FDA Recall
    Open, Classified ·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·March 14, 2023

    Cirq Arm System 2.0

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code OLO·March 2, 2023

    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026

    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

    FDA Recall
    Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 25, 2022