BEUDAMED
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    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PXU·June 11, 2024

    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 27, 2026

    iQ Waste Well Adapter, Part Number: 700-3393

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    REV 2 Flowcell Capsule Spare, Part Number: C04154

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·November 28, 2023

    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·May 31, 2023

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Recall
    Open, Classified ·Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia·Product code IZL·August 31, 2022

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 22, 2024

    MICRO-X Rover Mobile X-ray System, # MXU-RV19

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 23, 2024

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·April 4, 2025

    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.

    FDA Recall
    Open, Classified ·GRAPHENANO DENTAL SL Calle De Pau Casals·Product code EBI·October 24, 2023

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

    BD Recanalization System, REF: BDRECANSYSTEM

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc·Product code PDU·November 14, 2023