BEUDAMED
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    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).

    FDA Recall
    Open, Classified ·Westmed, Inc.·Product code BZA·September 27, 2024

    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

    FDA Recall
    Open, Classified ·Myelotec, Inc.·Product code HRX·March 2, 2017

    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025

    MAGEC 1 System

    FDA Recall
    Open, Classified ·NuVasive Specialized Orthopedics, Inc.·Product code PGN·June 25, 2019

    SMV DSX New Line, System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code IYX·December 10, 2025

    SMV BodyTrack, System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code IYX·December 10, 2025

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Recall
    Open, Classified ·On-X Life Technologies, Inc.·Product code LWQ·February 1, 2026

    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane

    FDA Recall
    Open, Classified ·ACTIM OY Klovinpellontie 3 Espoo Finland·Product code OAM·November 23, 2023

    Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

    FDA Recall
    Open, Classified ·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code OAS·October 28, 2021

    Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)

    FDA Recall
    Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

    FDA Recall
    Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)

    FDA Recall
    Open, Classified ·SURGIFY MEDICAL OY Otakaari 5 I Espoo Finland·Product code HBE·April 30, 2026

    TruSignal Ear Sensor, REF TS-E-D; Oximeter

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code DPZ·May 19, 2023

    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code DPZ·May 19, 2023

    CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, 2) 2078633-010, 3) 2078633-012, 4) 2078633-017, 5) 2078633-028, 6) 2095802-001-54069330, 7) 2095802-001-554922, 8) 2095802-001-554923, 9) 2095802-001-554924, 10) 2095802-001-554925, 11) 2095802-001-554926, 12) 2095802-001-554927, 13) 2095802-001-554928, 14) 2095802-001-555120, 15) 2095802-001-556223, 16) 2095802-001-557346, 17) 2095802-001-558678, 18) 2095802-001-558707, 19) 2095802-001-559208, 20) 2095802-001-559337, 21) 2095802-001-559916, 22) 2095802-001-560446, 23) 2095802-001-560519, 24) 2095802-001-560520, 25) 2095802-001-560521, 26) 2095802-001-560522, 27) 2095802-001-560637, 28) 2095802-001-560803, 29) 2095802-001-561557, 30) 2095802-001-562090, 31) 2095802-001-562136, 32) 2095802-001-562249, 33) 2095802-001-562799, 34) 2095802-001-563317, 35) 2095802-001-563770, 36) 2095802-001-563771, 37) 2095802-001-564033, 38) 2095802-001-564174, 39) 2095802-001-565603, 40) 2095802-001-566307, 41) 2095802-001-566308, 42) 2095802-001-566696, 43) 2095802-001-566798, 44) 2095802-001-566816, 45) 2095802-001-566825, 46) 2095802-001-566826, 47) 2095802-001-566925, 48) 2095802-001-567844, 49) 2095802-001-568125, 50) 2095802-001-568726, 51) 2095802-001-568765, 52) 2095802-001-569226, 53) 2095802-001-569235, 54) 2095802-001-569318, 55) 2095802-001-569322, 56) 2095802-001-569329, 57) 2095802-001-569332, 58) 2095802-001-569426, 59) 2095802-001-569860, 60) 2095802-001-569871, 61) 2095802-001-569990, 62) 2095802-001-570062, 63) 2095802-001-570185, 64) 2095802-001-570746, 65) 2095802-001-570960, 66) 2095802-001-571048, 67) 2095802-001-571049, 68) 2095802-001-571801, 69) 2095802-001-571807, 70) 2095802-001-572988, 71) 2095802-001-572991, 72) 2095802-001-573205, 73) 2095802-001-574167, 74) 2095802-001-574403, 75) 2095802-001-574569, 76) 2095802-001-574570, 77) 2095802-001-574685, 78) 2095802-001-575604, 79) 2095802-001-575842, 80) 2095802-001-576569, 81) 2095802-001-577254, 82) 2095802-001-577260, 83) 2095802-001-577472, 84) 2095802-001-577688, 85) 2095802-001-578467, 86) 2095802-001-578468, 87) 2095802-001-579029, 88) 2095802-001-579134, 89) 2095802-001-579366, 90) 2095802-001-579526, 91) 2095802-001-579590, 92) 2095802-001-579604, 93) 2095802-001-579692, 94) 2095802-001-579926, 95) 2095802-001-579933, 96) 2095802-001-580487, 97) 2095802-001-580731, 98) 2095802-001-581010, 99) 2095802-001-581094, 100) 2095802-001-581417, 101) 2095802-001-581433, 102) 2095802-001-582510, 103) 2095802-001-582710, 104) 2095802-001-582906, 105) 2095802-001-582907, 106) 2095802-001-583150, 107) 2095802-001-583551, 108) 2095802-001-583553, 109) 2095802-001-583888, 110) 2095802-001-583970, 111) 2095802-001-584288, 112) 2095802-001-584547, 113) 2095802-001-584810, 114) 2095802-001-585047, 115) 2095802-001-585468, 116) 2095802-001-585907, 117) 2095802-001-586028, 118) 2095802-001-586829, 119) 2095802-001-587286, 120) 2095802-001-587726, 121) 2095802-001-587767, 122) 2095802-001-587770, 123) 2095802-001-588006, 124) 2095802-001-588111, 125) 2095802-001-588571, 126) 2095802-001-589110, 127) 2095802-001-589168, 128) 2095802-001-589304, 129) 2095802-001-589326, 130) 2095802-001-589329, 131) 2095802-001-589511, 132) 2095802-001-589655, 133) 2095802-001-589796, 134) 2095802-001-589799, 135) 2095802-001-589801, 136) 2095802-001-589993, 137) 2095802-001-590263, 138) 2095802-001-590270, 139) 2095802-001-590640, 140) 2095802-001-590643, 141) 2095802-001-590645, 142) 2095802-001-590648, 143) 2095802-001-590649, 144) 2095802-001-590651, 145) 2095802-001-590652, 146) 2095802-001-591048, 147) 2095802-001-591102, 148) 2095802-001-591244, 149) 2095802-001-591246, 150) 2095802-001-591718, 151) 2095802-001-592666, 152) 2095802-001-592669, 153) 2095802-001-592683, 154) 2095802-001-592983, 155) 2095802-001-593000, 156) 2095802-001-593024, 157) 2095802-001-593039,

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·April 5, 2024

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·April 5, 2024

    CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001

    FDA Recall
    Open, Classified ·GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland·Product code MHX·September 26, 2025