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    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·October 8, 2024

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 15, 2024

    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 11, 2021

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·September 27, 2023

    Brand Name: Leksell Vantage Arc System REF: 1053958

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code HAW·March 19, 2026

    NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

    FDA Recall
    Open, Classified ·Navinetics Inc·Product code HAW·February 26, 2024

    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

    FDA Recall
    Open, Classified ·Globus Medical, Inc.·Product code HAW·December 11, 2023

    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·March 1, 2023

    Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

    FDA Recall
    Open, Classified ·Globus Medical, Inc.·Product code HAW·December 11, 2023

    Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code HAW·September 30, 2025

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    FDA Recall
    Open, Classified ·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·September 25, 2024

    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code HAW·August 31, 2021

    AxiEM" Non-Invasive Patient Tracker

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·December 15, 2022

    StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·April 11, 2023

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    FDA Recall
    Open, Classified ·FHC, Inc.·Product code HAW·October 4, 2024

    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HAW·November 12, 2025