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    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code NBC·November 11, 2015

    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

    FDA Recall
    Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code NBC·April 30, 2018

    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

    FDA Recall
    Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code JHX·April 30, 2018

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

    VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    FDA Recall
    Terminated ·Biomerieux France Chemin De L'Or Chemin De L'Orme Marcy L'Etoile France·Product code NBC·April 15, 2016

    Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA for C. trachomatis and the genomic DNA of N. gonorrhoeae in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens.

    FDA Recall
    Terminated ·Abbott Molecular·Product code LSK·December 20, 2010

    NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·October 31, 2013

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

    Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NBC·April 5, 2012

    Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code DXN·October 12, 2011

    SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.

    FDA Recall
    Terminated ·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code DXN·December 31, 2009

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

    FDA Recall
    Terminated ·Kelyniam Global, Inc.·Product code GXN·June 10, 2017

    EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DXN·March 21, 2019

    ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DXN·May 18, 2015