BEUDAMED
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    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023

    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code NBC·November 1, 2018

    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297

    FDA Recall
    Open, Classified ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022

    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

    FDA Recall
    Open, Classified ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022

    Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)

    FDA Recall
    Open, Classified ·Product code LIT·September 19, 2024

    TourniKwik Tourniquet Set (CFN 79012)

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code GDJ·May 16, 2024

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code EZW·April 3, 2025

    Puritan Bennett 560 Ventilator, PB560, CFN 4096600

    FDA Recall
    Open, Classified ·Covidien Llc·Product code QOS·August 19, 2022

    InPen App, Model/CFN Number: MMT-8061 (Android Users)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code NDC·November 13, 2025

    InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code NDC·June 16, 2025

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

    FDA Recall
    Open, Classified ·Product code GDW·September 25, 2025

    Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;

    FDA Recall
    Open, Classified ·Product code GDW·September 25, 2025

    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

    FDA Recall
    Open, Classified ·Product code GEI·March 5, 2021

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    FDA Recall
    Open, Classified ·Covidien LLC·Product code OLW·July 26, 2018

    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·December 3, 2025

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 21, 2024

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 21, 2024

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 21, 2024

    Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP

    FDA Recall
    Open, Classified ·Product code MSD·March 15, 2024

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 21, 2024