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    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·October 21, 2008

    Model 4000 Monitor component of the LifeVest Wearable Defibrillator

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 24, 2010

    Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number 10A0889-A01. Specifically the 3 Therapy Electrode Pads attached to the Electrode Belt.

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·April 27, 2007

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).

    FDA Recall
    Terminated ·Zoll Lifecor Corporation·Product code MVK·September 14, 2007

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016

    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·April 22, 2016

    Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code LRO·June 6, 2022

    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    FDA Recall
    Terminated ·Burlington Medical, LLC·Product code EAJ·June 7, 2019

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

    AcrySof ReSTOR Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    AcrySof ReSTOR Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code MFK·March 27, 2025

    AcrySof Intraocular Lens

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code MFK·December 14, 2006

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Recall
    Terminated ·Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France·Product code NIK·July 9, 2018

    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Recall
    Terminated ·Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France·Product code NIK·July 9, 2018