64 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
FDA Recall
Terminated
·Baro-Therapies, Inc·Product code CBF·August 8, 2014
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
FDA Recall
Terminated
·Sechrist Industries Inc·Product code CBF·August 28, 2008
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code EOQ·June 8, 2023
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·December 17, 2013
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
FDA Recall
Terminated
·Dale Medical Products, Inc.·Product code CBH·March 24, 2017
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code CAF·March 31, 2021
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
FDA Recall
Terminated
·Nephron Pharmaceuticals Corp.·Product code CAF·November 16, 2015
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
FDA Recall
Terminated
·SANRAI INTERNATIONAL LLC·Product code CAF·August 29, 2018
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Recall
Terminated
·Aerogen Ltd. Galway Business Park Dangan Galway Ireland·Product code CAF·September 2, 2014
Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
FDA Recall
Terminated
·Compass Health Brands·Product code CAF·April 20, 2015
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
Portex 1000 ml Sterile Water USP Pour Bottle
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
Medline Prefilled 350 ml Sterile
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017