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    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)

    FDA Recall
    Terminated ·Hologic, Inc·Product code GDF·August 2, 2016

    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GDF·May 3, 2013

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GDF·August 26, 2014

    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    FDA Recall
    Terminated ·Hologic, Inc·Product code GDF·August 2, 2016

    (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code GDF·March 28, 2017

    Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220 For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.

    FDA Recall
    Terminated ·Carefusion 2200 Inc 1500 S Waukegan Rd Mpwm Bldg. Waukegan IL 60085-6728·Product code GDF·June 25, 2010

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm, 250 mm long, dilating. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007

    (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    Angiotech Needle Guide. Needle Guide for Lorad Stereo Loc. STERILE. Product Number: LNGC14GX, LNGC1619PX, LNGC2022YX, LNGO1619PX, LNGO2022YX. 510k Exempt. Qty Dist. - 13,800. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Needle Guide

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GDF·September 1, 2009

    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OZN·October 16, 2013

    16 G / 5F Dual Lumen L-Cath catheter only.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005

    16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005