BEUDAMED
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    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025

    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

    FDA Recall
    Open, Classified ·Burlington Medical, LLC·Product code IWO·February 11, 2026

    Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

    FDA Recall
    Terminated ·CaridianBCT, Inc.·Product code LKN·October 26, 2011

    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code JPA·August 27, 2004

    Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

    FDA Recall
    Terminated ·Gambro BCT, Inc.·Product code LKN·September 18, 2007

    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    FDA Recall
    Terminated ·Caridian BCT, Incorporated·Product code LKN·September 21, 2011

    Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.

    FDA Recall
    Terminated ·CaridianBCT, Inc.·Product code KZE·June 1, 2010

    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

    FDA Recall
    Open, Classified ·Hager & Meisinger Gmbh Ronsdorferstrasse 22 Dusseldorf Germany·Product code EJL·November 7, 2018

    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

    FDA Recall
    Open, Classified ·Streck·Product code GIM·February 23, 2017

    Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

    FDA Recall
    Terminated ·Blue Belt Technologies MN·Product code KKX·July 19, 2013

    Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.

    FDA Recall
    Terminated ·CaridianBCT, Inc.·Product code LKN·May 4, 2012

    BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JKA·November 17, 2015

    MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code BSY·August 3, 2022

    GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code DXJ·January 28, 2022

    Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·June 28, 2019

    Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018