BEUDAMED
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    PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code ORA·May 22, 2023

    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 2, 2023

    HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

    FDA Recall
    Open, Classified ·Hycor Biomedical LLC·Product code DHB·July 25, 2018

    Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G

    FDA Recall
    Open, Classified ·Apellis Pharmaceuticals, Inc.·Product code FMI·August 22, 2023

    HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·January 23, 2020

    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·May 28, 2021

    Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

    FDA Recall
    Open, Classified ·Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom·Product code MHX·May 25, 2021

    HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·January 23, 2020

    Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

    FDA Recall
    Open, Classified ·Steris Corporation·Product code HBM·December 12, 2023

    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

    FDA Recall
    Open, Classified ·Steris Corporation·Product code HBM·December 12, 2023

    Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code FMZ·July 26, 2019

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 23, 2020

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024