BEUDAMED
    21 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    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

    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JHI·May 25, 2022

    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJY·April 24, 2025

    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LCP·April 24, 2025

    ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JGY·April 24, 2025

    ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JGY·April 24, 2025

    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJX·January 9, 2024

    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

    Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·February 26, 2024

    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024

    Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007

    FDA Recall
    Open, Classified ·PYRAMES INC·Product code DXN·February 24, 2025

    Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR, 106364; i) SPOT VS POWER SUPPLY SET/PLUG4/UK, 106366; j) SPOT VS POWER SUPPLY SET/PLUG7/SA, 106368; for use during vision screening

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXN·March 26, 2024

    Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

    Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOTH, MOBILE, UK, Product Code 34BXST-4; f) PROBP 3400, BLUETOOTH, MOBILE, ZA, Product Code 34BXST-7; g) PROBP 3400, SUREBP, MOBILE, EU, Product Code 34XFST-2; h) PROBP 3400, SUREBP, MOBILE, UK, Product Code 34XFST-4; i) PROBP 3400, SUREBP, MOBILE, AU, Product Code 34XFST-6; j) PROBP 3400, SUREBP, MOBILE, ZA, Product Code 34XFST-7; k) PROBP 3400, MOBILE, EU, Product Code 34XXST-2; l) PROBP 3400, MOBILE, UK, Product Code 34XXST-4; m) PROBP 3400, MOBILE, AU, Product Code 34XXST-6; n) PROBP 3400, MOBILE, ZA, Product Code 34XXST-7; o) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-5WT-2; p) PROBP MOBILE STAND CORD ASSY UK, Product Code PWCD-5WT-4; q) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-5WT-6; r) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-5WT-7; s) PROBP MOBILE STAND CORD ASSY EUROPE, Product Code PWCD-6WT-2; t) PROBP MOBILE STAND CORD ASSY AUST, Product Code PWCD-6WT-6; u) PROBP MOBILE STAND CORD ASSY S. AFRICA, Product Code PWCD-6WT-7

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXN·March 26, 2024

    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024

    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

    Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXN·March 26, 2024

    MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DXN·August 30, 2024