Medical Devices

2018 Medical Device Recalls

The list below contains recalls that were issued in 2018.

2018 Recalls

Device NameDate
Vyaire Medical, Inc. Recalls Tri-Flo Subglottic Suction System Due to Risk of Device Breakage 09/04/18
Compass Health Brands Recalls CPAP Mask Cushion Devices Due to Possible Air Leaks 08/31/18
BioMerieux Recalls VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards Due to False Results for some strains of methicillin-resistant Staphylococcus aureus (MRSA) 08/23/18
Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle 08/10/18
Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery 08/10/18
Qiagen Sciences LLC. Recalls the AmniSure ROM Test Due to Lack of Control Line - Which May Lead to Misinterpretation of Test Results 08/08/18
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 06/22/18
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 06/06/18
Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller 06/01/18
Abbott Recalls the HeartMate 3™ Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion 05/22/18
Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use 05/18/18
Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design 05/11/18
Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error 05/09/18
Terumo Recalls Sarns™ TCM and TCM II Cooling and Heating Systems and HX2™ Temperature Management Systems Due to Revised Cleaning Instructions 05/07/18
Becton Dickinson (BD) and Company Recalls Vacutainer® EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests 03/23/18
Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes 03/22/18
Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery 02/26/18
Vyaire Medical Recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error 01/30/18
Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow 01/11/18
Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due to improper seal of the sheath hub 01/02/18


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Page Last Updated: 09/04/2018
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