BEUDAMED
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    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·June 1, 2022

    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·October 14, 2022

    ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code GKP·July 13, 2023

    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    FDA Recall
    Open, Classified ·C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden·Product code IYE·April 22, 2025

    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

    FDA Recall
    Open, Classified ·Cypress Medical Products LLC·Product code FMF·August 6, 2024

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAS·October 2, 2023

    HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAS·June 8, 2023

    IQon Spectral CT; Product Code (REF): 728332;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Spectral CT 7500 on Rails; Product Code (REF): 728334;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Brilliance iCT; Product Code (REF): 728306;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Spectral CT; Product Code (REF): 728333;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019