BEUDAMED
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    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NKE·August 28, 2017

    Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code NKE·June 7, 2013

    CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NKE·June 24, 2006

    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code NKE·November 9, 2015

    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NKE·August 28, 2017

    Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NKE·August 28, 2017

    Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·June 21, 2018

    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·November 29, 2017

    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use

    FDA Enforcement
    Class II ·Terminated·Medtronic Neurosurgery·October 3, 2018

    product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''

    FDA Recall
    Terminated ·Pascal Co Inc·Product code MED·August 9, 2005

    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 13, 0012

    diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.

    FDA Recall
    Terminated ·DiaDexus, Inc·Product code NOE·November 4, 2008

    3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010

    3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.

    FDA Recall
    Terminated ·Product code KGX·January 29, 2010