BEUDAMED
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    Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

    FDA Recall
    Terminated ·Alpha Omega Engineering·Product code GZL·September 4, 2018

    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.

    FDA Recall
    Terminated ·Bio Rad Laboratories, Inc.·Product code NOM·January 25, 2005

    Platelia Aspergillus EIA

    FDA Recall
    Terminated ·Bio Rad Laboratories, Inc.·Product code NOM·November 6, 2003

    Misys Laboratory version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·December 20, 2002

    Misys Laboratory versions 5.23 and 5.3

    FDA Recall
    Terminated ·Sunquest Information Systems·November 22, 2002

    DL2000 Data Manager Software, Version 6.4.108

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JQP·November 5, 2004

    EM2 NC AEM Monitor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2M NC AEM Monitor, (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·January 27, 2004

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Misys Laboratory System version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·April 1, 2003

    Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·July 6, 2005

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Misys Laboratory System, versions 5.2, 5.23 and 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·June 10, 2003

    Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3

    FDA Recall
    Terminated ·Misys Healthcare Systems·Product code JQP·January 17, 2003

    Misys Laboratory versions 5.23 and 5.3 with Callback

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 18, 2002

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·July 21, 2015

    Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·August 16, 2004

    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.

    FDA Recall
    Terminated ·Neomed Inc·Product code KNT·October 24, 2018

    NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement and is not intended for use beyond 30 days.

    FDA Recall
    Terminated ·Neomed Inc·Product code FPD·June 4, 2018