BEUDAMED
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    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc·Product code CGJ·March 25, 2022

    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CGJ·March 5, 2018

    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGJ·July 12, 2018

    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGJ·August 7, 2012

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code CGJ·November 16, 2016

    DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code CGJ·May 22, 2023

    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code CGJ·April 9, 2018

    VIDAS FSH, REF 30407-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code CGJ·September 22, 2021

    i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code KHP·January 15, 2020

    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LJT·April 21, 2026

    i-STAT CG4+ cartridge (white). List Number: 03P85-25.

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·May 17, 2018

    Brand Name Burn Navigator Model Numbers: Catalog 1120, Burn Navigator H2 Catalog 1125, Burn Navigator H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

    FDA Recall
    Terminated ·Arcos, Inc·Product code PDT·March 16, 2015

    Medex 3000 Series Syringe Infusion Pumps

    FDA Recall
    Terminated ·Medex Inc·Product code CAJ·February 16, 2004

    Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

    FDA Recall
    Open, Classified ·Capnia Inc·Product code CCJ·April 21, 2025