BEUDAMED
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    Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code HWR·October 4, 2007

    BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HWR·January 15, 2010

    Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument

    FDA Recall
    Terminated ·Smith & Nephew, Inc., Endoscopy Div.·Product code HWR·April 4, 2013

    Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855

    FDA Recall
    Terminated ·Pioneer Surgical Technology·Product code HWR·October 10, 2007

    Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System

    FDA Recall
    Terminated ·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code HWR·January 5, 2016

    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

    FDA Recall
    Terminated ·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code HWR·January 5, 2016

    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

    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

    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

    her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.

    FDA Recall
    Terminated ·American Medical Systems·Product code MNB·January 13, 2006

    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

    Jazzy Select 6 with XLR Port Harness

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

    Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NCW·August 25, 2020

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

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

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

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

    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

    FDA Recall
    Terminated ·Biogenex Laboratories, Inc.·Product code MVC·July 1, 2014

    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