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    Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.

    FDA Recall
    Terminated ·Medtronic Vascular, Inc.·Product code OTD·September 13, 2017

    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

    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

    Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007

    Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

    FDA Recall
    Terminated ·Steris Corporation·Product code FTD·February 23, 2010

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    FDA Recall
    Terminated ·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

    Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·January 9, 2004

    HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.

    FDA Recall
    Terminated ·MAQUET Inc.·Product code FTD·October 7, 2009

    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms.

    FDA Recall
    Terminated ·Steris Corp·Product code FTD·September 11, 2009

    Drager Surgical Lights Sola 500 and Sola 700.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code FTD·August 26, 2009