BEUDAMED
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    Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

    FDA Recall
    Open, Classified ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code LOX·September 3, 2019

    Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

    FDA Recall
    Open, Classified ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code LOX·September 3, 2019

    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

    FDA Recall
    Terminated ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code DYB·May 12, 2020

    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

    FDA Recall
    Terminated ·Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland·Product code LOX·July 13, 2017

    TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario·Product code NAW·February 24, 2009

    SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009

    SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009

    SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·March 17, 2010

    SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·March 17, 2010

    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System

    FDA Recall
    Open, Classified ·ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL 1111 Chomedey (A-13) E Laval Canada·Product code LXH·July 4, 2024

    OMTech Desktop Laser Engraver

    FDA Recall
    Open, Classified ·Rygel Advanced Machines d/b/a Omtech Laser·Product code RIM·June 7, 2024

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Recall
    Open, Classified ·DICOM Grid, Inc. d/b/a Ambra Health·Product code LLZ·June 23, 2022

    OMTech Desktop Laser Engraver

    FDA Enforcement
    Class II ·Ongoing·Rygel Advanced Machines d/b/a Omtech Laser·June 19, 2024

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Enforcement
    Class II ·Ongoing·DICOM Grid, Inc. d/b/a Ambra Health·October 5, 2022

    400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.

    FDA Recall
    Terminated ·ErgoSafe Product LLC dba Prism Medical Services 480 University Avenue, Suite 510 Toronto, ON Canada M5GiV2·Product code FSA·May 10, 2013

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Recall
    Terminated ·Clorox Healthcare Holdings, LLC (dba HealthLink) 3611 Saint Johns Bluff Rd S Ste 1 Suite 1 Jacksonville FL 32224-2679·Product code LRY·March 18, 2013

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Recall
    Terminated ·Clorox Healthcare Holdings, LLC (dba HealthLink) 3611 Saint Johns Bluff Rd S Ste 1 Suite 1 Jacksonville FL 32224-2679·Product code LRY·March 18, 2013

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Recall
    Terminated ·Clorox Healthcare Holdings, LLC (dba HealthLink) 3611 Saint Johns Bluff Rd S Ste 1 Suite 1 Jacksonville FL 32224-2679·Product code LRY·March 18, 2013