FDA Medical Device Recalls

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to patients. The links give details about what to do if you own or use one of these products. If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database.

Please note that the FDA lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice

Learn more about medical device recalls here.

The list below contains recalls that were issued in 2018.

2018 FDA Recalls

Device Name Date
Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect 11/27/18
Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness 11/26/18
Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing 11/23/18
Beckman Coulter Life Sciences Recalls FC 500 and the EPICS XL Series Flow Cytometers Due to Risk of Inaccurate Results 11/20/18
GE Healthcare Recalls Millennium Nuclear Medicine Systems Due to Risk of Detector Detaching and Falling 11/15/18
Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results 11/01/18
Maquet Datascope Corp./Getinge Group Recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) Due to Possible Malfunction and Failure at High Altitudes 11/01/18
Alcon Research, LTD. Recalls CyPass® Micro-Stent Systems Due to Risk of Endothelial Cell Loss 10/24/18
Endologix, Inc. Recalls AFX Endovascular AAA Systems Due to Risk of Type III Endoleaks 10/15/18
Pro-Med Instruments Recalls the DORO LUCENT Headrest Due to Possible Malfunction and Failure 09/28/18
Ventana Medical Systems Recalls Multiple Detection Kits Due to Potential for False Negative Results Caused by Reagent Dispenser Issues 09/28/18
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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