Advanced Instruments, LLC - OsmoPRO MAX Automated Osmometer - Class 2 Recall
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 30, 2024 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy M1000D SenTiva Generator - Class 2 Recall
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 5, 2020 Category: Medical Devices Source Type: alerts

The Magstim Company Limited - Rapid2 - Class 2 Recall
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts

The Magstim Company Limited - Horizon; The Rapid - Class 2 Recall
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts

LivaNova USA Inc - VNS Therapy SenTiva Generator Model 1000 - Class 2 Recall
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2020 Category: Medical Devices Source Type: alerts

The Magstim Company Limited - Rapid2 Therapy System - Class 2 Recall
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 12, 2018 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - VNS(R) Therapy Programmer - Class 2 Recall
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressan...
Source: Medical Device Recalls - February 8, 2018 Category: Medical Devices Source Type: alerts

DEPRESSION - MOOD - DISTRESS (Angelica Sinensis, Radix, Aralia Quinquefolia, Arg. Nit., Arsenicum Alb., Berber. Aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali Brom., Kali Carb., Mag. Phos., Nat. Carb., Nat. Mur., Phosphorus, Salix Nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo) Pellet [Newton Laboratories, Inc.]
Updated Date: Dec 15, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 15, 2017 Category: Drugs & Pharmacology Source Type: alerts

DEPRESSION - MOOD - DISTRESS (Angelica Sinensis, Radix, Aralia Quinquefolia, Arg. Nit., Arsenicum Alb., Berber. Aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali Brom., Kali Carb., Mag. Phos., Nat. Carb., Nat. Mur., Phosphorus, Salix Nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo) Liquid [Newton Laboratories, Inc.]
Updated Date: Dec 14, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 14, 2017 Category: Drugs & Pharmacology Source Type: alerts

Cyberonics, Inc - Model 106 AspireSR Generators - Class 2 Recall
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and ha...
Source: Medical Device Recalls - August 12, 2017 Category: Medical Devices Source Type: alerts

Cyberonics, Inc - Model 105 Aspire HC and Generators - Class 2 Recall
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and ha...
Source: Medical Device Recalls - August 12, 2017 Category: Medical Devices Source Type: alerts

Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals: Recall - Super-potent Product
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - February 17, 2016 Category: American Health Source Type: alerts

MOODBRITE SEASONAL DEPRESSION SYMPTOM RELIEF (Anacardium Orientale, Larix Decidua, Flos, Aurum Metallicum, Avena Sativa, Calcarea Carbonica, Cinchona Officinalis, Hypericum Perforatum, Kali Bromatum, Natrum Sulphuricum, Tabacum, Ignatia Amara, Pulsatilla, Sepia, Sinapis Arvensis, Flos, Cimicifuga Racemosa, Natrum Carbonicum, Phosphoricum Acidum, Phosphorus, Carpinus Betulus, Flos) Liquid [Hello Life, Inc.]
Updated Date: Jan 22, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 22, 2016 Category: Drugs & Pharmacology Source Type: alerts

Spacelabs Healthcare Inc - Spacelabs Healthcare CardioCall ECG Event Recorder - Class 2 Recall
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The event recorder, called the CardioCall, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called Looping mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the Post-Activation mode, in which the device ...
Source: Medical Device Recalls - October 30, 2015 Category: Medical Equipment Source Type: alerts

DEPRESSION COMPOSITION (Not Applicable) Liquid [Synergy Formulas, Inc.]
Updated Date: Oct 1, 2014 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - October 1, 2014 Category: Drugs & Pharmacology Source Type: alerts