BEUDAMED
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    Filters Regulation: Us FDA × Status: Open, Classified × Clear all

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 860010-1L

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 360020-1EP

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 360020-1P

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·February 19, 2024

    VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DLJ·April 14, 2023

    HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·February 19, 2024

    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

    FDA Recall
    Open, Classified ·Brasseler USA I Lp·Product code EJL·January 11, 2024

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    FDA Recall
    Open, Classified ·Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804·Product code NZU·October 23, 2023

    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GEI·November 2, 2022

    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GEI·November 2, 2022

    Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GEI·November 2, 2022

    CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GEI·November 2, 2022

    Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code GEI·November 2, 2022