FDA Alerts
Class 1 Recall: Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery
Class 1 Recall: Qiagen Sciences LLC. Recalls the AmniSure ROM Test Due to Lack of Control Line - Which May Lead to Misinterpretation of Test Results
Class 1 Recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 Recalled Due to Misinterpretation of Display Messages for Out of Range Values
Class 1 Recall: Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy
Class 1 Recall: Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller
Class 1 Recall: Abbott Recalls the HeartMate 3 Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion
Class 1 Recall: Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use
Class 1 Recall: Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design
Class 2 Recall: Terumo Recalls Sarns" TCM and TCM II Cooling and Heating Systems and HX2" Temperature Management Systems Due to Revised Cleaning Instructions