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    COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code HHW·May 25, 2022

    GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    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

    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    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

    Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 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

    Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023

    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

    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

    FDA Recall
    Open, Classified ·Coloplast Manufacturing US, LLC·Product code FHW·March 1, 2023