BEUDAMED
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    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·September 28, 2017

    Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.

    FDA Recall
    Terminated ·Pride Mobility Products Corp·Product code INI·November 26, 2010

    Mamoray HDR-C PLUS Mammography film

    FDA Recall
    Terminated ·AGFA Corp.·Product code IWZ·February 16, 2006

    Jazzy Select with XLR Port Harness

    FDA Recall
    Terminated ·Pride Mobility Products Corp·Product code ITI·February 1, 2010

    Jazzy Select 6 with XLR Port Harness

    FDA Recall
    Terminated ·Pride Mobility Products Corp·Product code ITI·February 1, 2010

    Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193

    FDA Recall
    Terminated ·Patterson Medical Holdings, Inc.·Product code INN·April 17, 2009

    SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code BTA·July 28, 2006

    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·July 8, 2020

    Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

    FDA Recall
    Terminated ·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021

    Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 20CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0003-003. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

    Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

    Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012

    TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012

    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code JAQ·February 21, 2006

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·March 30, 2022

    Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·March 26, 2021

    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·February 25, 2005

    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·February 25, 2005

    Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles.

    FDA Recall
    Terminated ·Invacare Corp·Product code ITI·February 10, 2003