GE Healthcare Finland Oy - GE Healthcare CARESCAPE Monitor B850 - Class 2 Recall
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardi...
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare Finland Oy - GE Healthcare CARESCAPE Monitor B450 - Class 2 Recall
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oxi...
Source: Medical Device Recalls - October 11, 2018 Category: Medical Devices Source Type: alerts

Draeger Medical, Inc. - Apollo - Class 2 Recall
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Comm...
Source: Medical Device Recalls - June 20, 2018 Category: Medical Devices Source Type: alerts

Datex-Ohmeda, Inc. - CARESCAPE R860 ventilators with software version 10SP05 - Class 2 Recall
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. T...
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts

Datascope Corporation - Custom Tubing Pack with Bioline Coating - Class 2 Recall
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2018 Category: Medical Devices Source Type: alerts

Datascope Corporation - Custom Tubing Pack with Bioline Coating - Class 2 Recall
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2018 Category: Medical Devices Source Type: alerts

Teleflex Medical Europe Ltd - Teleflex MEDICAL HUDSON RCI(R) One Way Valve w. Capped Monitoring Port - Class 2 Recall
Teleflex MEDICAL HUDSON RCI(R) One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Teleflex Medical Europe Ltd - Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port - Class 2 Recall
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

ZOLL Medical Corporation - Portable Critical Care Ventilator - Class 2 Recall
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biologica...
Source: Medical Device Recalls - March 2, 2018 Category: Medical Devices Source Type: alerts

QVAR REDIHALER (Beclomethasone Dipropionate Hfa) Aerosol, Metered [Teva Respiratory, LLC]
Updated Date: Feb 7, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 7, 2018 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN Gas [Respiratory Care Partners, Inc]
Updated Date: Jan 22, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 22, 2018 Category: Drugs & Pharmacology Source Type: alerts

INFLUENZA PLUS (Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (Rsv), Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jan 4, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 4, 2018 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN Gas [Mercy Home Respiratory Care And Medical Supply]
Updated Date: Dec 26, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 26, 2017 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN (Oxygen) Gas [Genesis Respiratory Services]
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

OXYGEN Gas [North Central Respiratory, Inc]
Updated Date: Dec 11, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 11, 2017 Category: Drugs & Pharmacology Source Type: alerts

RESPIRATORY UPPER TERRAIN (Euphorbium Officinarum, Histaminium Hydrochloricum, Hydrastis Canadensis, Kali Bichromicum, Luffa Operculata, Pulsatilla.) Liquid [OHM PHARMA INC.]
Updated Date: Nov 29, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 29, 2017 Category: Drugs & Pharmacology Source Type: alerts

INFLUENZA PLUS (Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (Rsv), Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride) Liquid [Deseret Biologicals, Inc.]
Updated Date: Nov 14, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 14, 2017 Category: Drugs & Pharmacology Source Type: alerts

ARMONAIR RESPICLICK (Fluticasone Propionate) Powder, Metered [Teva Respiratory, LLC]
Updated Date: Aug 7, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 7, 2017 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY SUPPORT (Allium Cepa, Echinacea (Angustifolia), Eucalyptus Globulus, Salvia Officinalis, Dulcamara, Euphrasia Officinalis, Hydrastis Canadensis, Natrum Muriaticum, Sabadilla, Viscum Album, Mucosa Nasalis Suis, Aconitum Napellus, Ammonium Carbonicum, Arsenicum Iodatum, Bryonia (Alba), Gelsemium Sempervirens, Kali Bichromicum, Mercurius Vivus, Nux Vomica, Pulsatilla (Pratensis), Rhus Tox) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jun 7, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 7, 2017 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY STAPH/STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Tablet [Deseret Biologicals, Inc.]
Updated Date: Jun 1, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 1, 2017 Category: Drugs & Pharmacology Source Type: alerts

AIRDUO RESPICLICK (Fluticasone Propionate And Salmeterol) Powder, Metered [Teva Respiratory, LLC]
Updated Date: Apr 25, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 25, 2017 Category: Drugs & Pharmacology Source Type: alerts

INFLUENZA PLUS (Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (Rsv), Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride) Liquid [Deseret Biologicals, Inc.]
Updated Date: Mar 14, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 14, 2017 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN, COMPRESSED (Oxygen) Gas [Pulmocare Respiratory Services, Inc.]
Updated Date: Feb 21, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 21, 2017 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY STAPH STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jan 12, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 12, 2017 Category: Drugs & Pharmacology Source Type: alerts

UPPER RESPIRATORY STAPH STREP COMBINATION (Staphylococcus Aureus, Klebsiella Pheumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans) Liquid [Deseret Biologicals, Inc.]
Updated Date: Jul 26, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 26, 2016 Category: Drugs & Pharmacology Source Type: alerts

Nephron Pharmaceuticals Corp. - Sodium Chloride Inhalation Solution - Class 2 Recall
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2016 Category: Medical Equipment Source Type: alerts

Nephron Pharmaceuticals Corp. - Sodium Chloride Inhalation Solution - Class 2 Recall
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 28, 2016 Category: Medical Equipment Source Type: alerts

Ventlab LLC - STATCheck - Class 2 Recall
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients> 2.2 kilograms (5lbs.). (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2016 Category: Medical Equipment Source Type: alerts

Imbruvica (ibrutinib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) June 2016 ADVERSE REACTIONS Postmarketing Experience (Addition) Respiratory disorders: interstitial lung disease (includes... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
Manufacturing defect causes an increase in temperature within battery that may cause a fire. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 27, 2016 Category: American Health Source Type: alerts

CINQAIR (Reslizumab) Injection, Solution, Concentrate [Teva Respiratory, LLC]
Updated Date: Apr 18, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 18, 2016 Category: Drugs & Pharmacology Source Type: alerts

Philips Medical Systems, Inc. - Philips MultiDiagnost - Class 2 Recall
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 1, 2016 Category: Medical Equipment Source Type: alerts

OXYGEN Gas [Baystate Home Infusion Respiratory Services]
Updated Date: Mar 17, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 17, 2016 Category: Drugs & Pharmacology Source Type: alerts

Klonopin (clonazepam) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   March 2016 PRECAUTIONS Respiratory Compromise: Klonopin should be used with caution in patients with compromised respiratory... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology 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

UPPER RESPIRATORY STAPH STREP COMBO (Staphylococcus Aureus, Klebsiella Pneumoniae, Haemophilus Influenzae,) Liquid [Apotheca Company]
Updated Date: Jan 29, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 29, 2016 Category: Drugs & Pharmacology Source Type: alerts

RESPITROL RESPIRATORY SYMPTOM RELIEF (Ammonium Carbonicum, Antimonim Arsenicosum, Antimonium Tartaricum, Arsenicum Album, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum) 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

Mercury Enterprises, Inc. dba Mercury Medical - Mercury Medical NeoTee - Class 2 Recall
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 13, 2016 Category: Medical Equipment Source Type: alerts

OHM RESPIRATORY LOWER TERRAIN (Aconitum, Aranea, Bryonia, Equisetum, Eupatorium Perf, Hydrastis, Juglans Reg, Kali Bic, Phosphorus, Sarsaparrilla, Sulphur) Liquid [OHM PHARMA INC.]
Updated Date: Jan 12, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 12, 2016 Category: Drugs & Pharmacology Source Type: alerts

Botox (onabotulinumtoxinA) 
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) January 2016 WARNINGS AND PRECAUTIONS Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN Gas [Inmon Respiratory Services Inc.]
Updated Date: Dec 10, 2015 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) - December 10, 2015 Category: Drugs & Pharmacology Source Type: alerts

Event Medical LTD - Inspiration Ventilator System - Class 1 Recall
Inspiration Ventilator System, i Series and LS 12.1 LCD The Inspiration 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support w...
Source: Medical Device Recalls - November 20, 2015 Category: Medical Equipment Source Type: alerts

EYE AND UPPER RESPIRATORY (Aconitum Napellus, Apis Mellifica, Kali Iodatum, Natrum Arsenicicum, Sambucus Nigra, Hepar Sulphuris Calcareum, Mercurius Vivus, Allium Cepa, Euphrasia Officinalis) Liquid [Only Natural Pet]
Updated Date: Nov 18, 2015 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) - November 18, 2015 Category: Drugs & Pharmacology Source Type: alerts

INFLUENZA PLUS (Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (Rsv), Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride) Liquid [Deseret Biologicals, Inc.]
Updated Date: Sep 11, 2015 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) - September 11, 2015 Category: Drugs & Pharmacology Source Type: alerts

OXYGEN Gas [Greene Respiratory Services, Inc]
Updated Date: Aug 24, 2015 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) - August 24, 2015 Category: Drugs & Pharmacology Source Type: alerts

Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Puritan Bennett 980 Ventilator System Universal and Neonatal Models - Class 1 Recall
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts

EYE AND UPPER RESPIRATORY (Aconitum Napellus, Apis Mellifica, Kali Iodatum, Natrum Arsenicicum, Sambucus Nigra, Hepar Sulphuris Calcareum, Mercurius Vivus, Allium Cepa, Euphrasia Officinalis) Liquid [Only Natural Pet]
Updated Date: Aug 5, 2015 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) - August 5, 2015 Category: Drugs & Pharmacology Source Type: alerts