Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction
Dräeger Medical, Inc. expanded on its voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters.
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GE Healthcare’s Recall of Ventilator Batteries Gets Class I Label from FDA Over Device Shutdown Risk
Due to their ability to cause the premature shutdown of GE Healthcare’s Carescape R860 ICU ventilators, the U.S. FDA has deemed GE Healthcare’s recall of more than 100,000 batteries as a Class 1 event—the most severe kind.
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Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect
Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.
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Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
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Avanos Medical’s Enteral Access System Gets FDA Class I Recall
Avanos Medical is experiencing an FDA Class I recall of its enteral access system due to reports of injuries and patient deaths.
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