BEUDAMED
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    Applied Blunt Tip Trocar Models C0717 and C0718

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code KXN·September 17, 2004

    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

    FDA Enforcement
    Class II ·Terminated·K2M, Inc·May 27, 2020

    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 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

    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

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

    FDA Recall
    Terminated ·Freudenberg Medical, Llc·Product code DYB·February 21, 2022

    Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

    FDA Recall
    Terminated ·Freudenberg Medical, Llc·Product code DYB·February 21, 2022

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020

    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

    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

    Oscar 2, Model 250 System

    FDA Recall
    Terminated ·Suntech Medical, Inc.·Product code DXN·April 20, 2020

    BD DTX Plus, Custom triple-line pressure monitoring kit.

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008

    ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).

    FDA Recall
    Terminated ·Welch Allyn Inc·Product code DXN·April 22, 2021

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Recall
    Terminated ·Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of)·Product code DXN·May 17, 2021

    BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device

    FDA Recall
    Terminated ·Becton Dickinson Medical Systems·Product code DXN·July 1, 2005