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Sources: EU EUDAMED, US FDA
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FDA Recall
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The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-110030120_REV D.pdf.pdf
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWS·November 28, 2017
Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.
FDA Recall
Terminated
·Invacare Corporation·Product code INI·December 7, 2011
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·January 15, 2020
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
FDA Recall
Open, Classified
·Beaver-Visitec International, Inc.·Product code HQF·December 5, 2025
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Recall
Terminated
·BrosMed Medical Co., Ltd. Bubugaogaofu Lou Lou 15th Songshan Lake Hi Dongguan China·Product code LIT·December 14, 2018
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·September 16, 2005
BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code MEG·November 24, 2008
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
FDA Recall
Terminated
·Vyaire Medical·Product code OEV·April 27, 2017