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    Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJX·April 21, 2010

    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKP·July 1, 2021

    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·December 30, 2020

    Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code HCG·November 12, 2008

    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code HCG·April 27, 2022

    Estrone RIA, REF: DSL8700

    FDA Recall
    Open, Classified ·Immunotech A.S. Radiova 1 Prague·Product code CGF·December 15, 2025

    Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code HCG·March 1, 2010

    B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

    FDA Recall
    Open, Classified ·Brahms GmbH Neuendorfstr. 25 Hennigsdorf Germany·Product code QWH·March 12, 2026

    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

    FDA Recall
    Terminated ·Radiometer America Inc·Product code JJS·September 7, 2017

    Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCZ·January 7, 2016

    Achillon minimally invasive Achilles tendon suture system

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MCZ·July 2, 2004

    Skin Stapler Removal Kit , catalog# 900-782

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCZ·December 8, 2011

    Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCZ·October 8, 2014

    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MCZ·February 23, 2024

    Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    SKIN STAPLE REMOVER

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code MCZ·October 23, 2017

    Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MCZ·November 15, 2023

    Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015 ; 5) SUTURING KIT, Pack Number MNS15015H; 6) SUTURING SET, Pack Number SUT21770 ; 7) SUTURE SET, Pack Number SUT21810 ; 8) SUTURING SET, Pack Number SUT21810H; 9) SUTURE TRAY , Pack Number SUT21830

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MCZ·April 8, 2024

    SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code MCZ·July 10, 2015

    Surgical Suture Kit

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code MCZ·April 22, 2022