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    Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.

    FDA Recall
    Open, Classified ·International Medical Industries, Inc.·Product code LHI·September 16, 2022

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·April 11, 2011

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·June 23, 2009

    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code IMI·January 5, 2005

    INTELECT TRANSPORT ULTRASOUND, electromechanical therapeutic ultrasound device, Model No. 2782, Chattanooga Group.

    FDA Recall
    Terminated ·Chattanooga Corp Inc·Product code IMI·February 28, 2008

    VECTRA GENISYS, electromechanical therapeutic ultrasound device, Model No. 2759, Chattanooga Group.

    FDA Recall
    Terminated ·Chattanooga Corp Inc·Product code IMI·February 28, 2008

    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

    FDA Recall
    Terminated ·GE Healthcare It·Product code JQP·March 12, 2013

    ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

    FDA Recall
    Terminated ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code QMT·June 2, 2021

    Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code FWX·May 21, 2008

    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.

    FDA Recall
    Terminated ·Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom·Product code CCW·September 21, 2011

    AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·August 23, 2010

    Ami HTX.

    FDA Recall
    Open, Classified ·Spectral Instruments Inc·Product code RCE·May 13, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

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

    I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742

    FDA Recall
    Terminated ·I-Flow Corporation·Product code MEB·November 29, 2006

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    FDA Recall
    Terminated ·Apollo Endosurgery Inc·Product code LTI·August 15, 2014

    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

    FDA Recall
    Terminated ·Verathon, Inc.·Product code IYO·November 30, 2015

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·October 27, 2014

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·January 6, 2014