BEUDAMED
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    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

    FDA Enforcement
    Class II ·Terminated·Carefusion 2200 Inc·October 1, 2014

    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code HTD·November 20, 2013

    outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HTD·November 26, 2013

    SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code HTD·September 3, 2009

    Holding Forceps for Trident Acetabular System; non Sterile; Catalog number 2105-0000; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430; Authorized representative in Europe: Stryker France, Cedex. France The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HTD·January 24, 2007

    Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.

    FDA Recall
    Terminated ·Synthes USA (HQ), Inc.·Product code HTD·September 3, 2009

    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

    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

    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

    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

    FDA Recall
    Terminated ·Micro-Tech Usa·Product code MND·October 5, 2020

    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

    FDA Enforcement
    Class II ·Terminated·Micro-Tech Usa·November 25, 2020

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·May 14, 2021

    ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·June 16, 2021

    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