BEUDAMED
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    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Recall
    Terminated ·Celera Corporation·Product code LDT·July 12, 2013

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Enforcement
    Class III ·Terminated·Celera Corporation·September 4, 2013

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Recall
    Terminated ·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019

    The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DAD·May 16, 2018

    Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code DTA·August 31, 2005

    Medtronic CapSureFix Novus Lead Model 5076.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code DTA·October 20, 2004

    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

    FDA Enforcement
    Class II ·Terminated·Bradshaw Medical Inc.·May 18, 2016

    Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Manufactured in the USA for Aksys Ltd., Lincolnshire, IL 60069 USA; Model 1M101

    FDA Recall
    Terminated ·Aksys, Ltd.·Product code KDI·June 26, 2006

    Peregrine 20 GA Endo Ocular Adjustable Laser Probe

    FDA Recall
    Terminated ·Peregrine Surgical Ltd·Product code HQF·July 19, 2010

    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).

    FDA Recall
    Terminated ·Given Imaging Ltd.·Product code NEZ·March 8, 2011

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code LRO·September 21, 2015

    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    FDA Recall
    Terminated ·Trilliant Surgical Ltd.·Product code HTW·July 20, 2015

    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NGY·August 11, 2015

    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HRM·May 25, 2017

    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G

    FDA Recall
    Terminated ·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018

    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G

    FDA Recall
    Terminated ·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018

    VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).

    FDA Recall
    Terminated ·International Biomedical, Ltd.·Product code LZF·May 24, 2013

    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code LRO·May 16, 2014

    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code MSS·September 5, 2016

    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NFG·March 1, 2016