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    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Recall
    Terminated ·Convatec Inc.·Product code KOD·February 7, 2014

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.

    FDA Recall
    Terminated ·American Medical Systems·Product code JCW·February 9, 2007

    AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.

    FDA Recall
    Terminated ·American Medical Systems·Product code JCW·February 9, 2007

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CGA·April 7, 2014

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CFR·October 23, 2014

    CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

    FDA Recall
    Terminated ·LMS Medical Systems Ltd·Product code HGM·January 11, 2005

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Recall
    Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

    Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".

    FDA Recall
    Terminated ·Product code RGB·November 19, 2010

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JDS·February 7, 2013

    Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code JDS·October 14, 2013

    Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDS·March 2, 2009

    TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JDS·April 4, 2014

    TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JDS·June 24, 2020

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    FDA Recall
    Terminated ·O-Two Medical Technologies, Inc.·Product code JBS·June 23, 2015

    PediaLift Access Device, Device Identifier: B751PDLFT0

    FDA Recall
    Terminated ·PediaLift LLC·Product code FMS·July 3, 2019

    Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDS·March 2, 2009

    INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JDS·February 7, 2013

    Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JDS·November 2, 2020