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  1. Medical Device Recalls

2023 Medical Device Recalls

The list below contains recalls that were issued in 2023.

2023 Medical Device Recalls

Device Name Date
Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas 12/20/2023
Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire (Updated 2/28/2024) 12/19/2023
Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch 12/19/2023
Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive 12/08/2023
Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures 12/05/2023
Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes 12/01/2023
Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line 12/01/2023
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections 11/27/2023
B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm 11/17/2023
Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device 11/16/2023
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages 11/15/2023
Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing 11/15/2023
Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing (Updated 03/07/2024) 11/14/2023
Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products 11/13/2023
Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling 11/06/2023
Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation 10/30/2023
Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds 10/24/2023
Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards 10/20/2023
Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits 10/18/2023
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile 09/20/2023
Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode 09/13/2023
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly 09/12/2023
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops 08/31/2023
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops 08/31/2023
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures 08/31/2023
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart 08/31/2023
Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice 08/30/2023
Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath 08/23/2023
Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots 08/17/2023
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns 08/17/2023
Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patients 08/14/2023
Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns 08/10/2023
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms 07/31/2023
GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings 07/28/2023
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent 07/27/2023
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism 07/26/2023
Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy 07/18/2023
Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns 07/17/2023
Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction 07/17/2023
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates 07/13/2023
Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop 07/14/2023
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients 07/11/2023
Teleflex and Arrow International Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation or Leakage 06/26/2023
BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use 06/12/2023
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support 06/05/2023
SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination 05/25/2023
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support 05/24/2023
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery 05/22/2023
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment 04/19/2023
Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy 04/07/2023
Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire 04/06/2023
Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss 03/31/2023
Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure 03/17/2023
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds 03/13/2013
Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris 02/16/2023
GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients 02/15/2023
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA 02/08/2023
Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy 02/02/2023
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect 01/30/2023
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure 01/27/2023
Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential 01/25/2023
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm 01/25/2023

 

 
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