Medical Device Recalls
Consumer-oriented medical device informationMedical Device Recalls
FDA medical device recalls are formal actions taken to remove or correct medical devices from the market when they pose a risk to public health or fail to comply with regulatory standards. These recalls are initiated by the FDA when it becomes aware of issues such as defects, malfunctions, or potential hazards associated with a particular medical device.
Recalls can vary in severity and are categorized into different classes based on the level of risk they pose to patients.
- Class I recalls are the most serious, indicating that there is a reasonable probability that using the device will cause serious adverse health consequences or death.
- Class II recalls suggest that using the device may cause temporary or reversible health problems, and
- Class III recalls involve devices that are unlikely to cause adverse health consequences but are in violation of FDA regulations.
Recalls are typically announced through FDA’s recall database and may involve communication with healthcare providers, patients, and the public to ensure awareness and appropriate action. Manufacturers are usually responsible for initiating recalls, although the FDA may request or mandate a recall if necessary. Following a recall, manufacturers may be required to implement corrective actions, such as repairing or replacing the affected devices, or providing refunds.
Overall, FDA medical device recalls play a crucial role in safeguarding public health by addressing potential risks associated with medical devices and ensuring the continued safety and effectiveness of these products in healthcare settings.
Medical Device Recalls
| Date | Description | More information |
|---|---|---|
| 04/04/2024 | Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft | Recall notice |
| 04/04/2024 | Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation | Recall notice |
| 04/03/2024 | Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage | Recall notice |
| 03/25/2024 | Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist | Recall notice |
| 03/21/2024 | Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death | Recall notice |
| 03/21/2024 | Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks | Recall notice |
| 03/14/2024 | Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist | Recall notice |
| 03/11/2024 | Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop | Recall notice |
| 03/11/2024 | Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist | Recall notice |
| 03/07/2024 | Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap | Recall notice |
| 03/07/2024 | Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock Connectors | Recall notice |
| 03/06/2024 | Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error | Recall notice |
| 03/05/2024 | Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions | Recall notice |
| 03/01/2024 | Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators | Recall notice |
| 02/29/2024 | Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch | Recall notice |
| 02/15/2024 | Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling | Recall notice |
| 02/14/2024 | Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions | Recall notice |
| 02/06/2024 | Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization | Recall notice |
| 01/31/2024 | Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist | Recall notice |
| 01/30/2024 | Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error | Recall notice |
| 01/16/2024 | ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility | Recall notice |
| 01/12/2024 | Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference | Recall notice |
| 01/11/2024 | ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices | Recall notice |
| 01/11/2024 | Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist | Recall notice |
| 01/08/2024 | Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns | Recall notice |
| 01/08/2024 | Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error | Recall notice |
| 12/20/2023 | 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 | Recall notice |
| 12/19/2023 | Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch | Recall notice |
| 12/19/2023 | Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire | Recall notice |
| 12/08/2023 | Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive | Recall notice |
| 12/05/2023 | Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures | Recall notice |
| 12/01/2023 | Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line | Recall notice |
| 12/01/2023 | Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes | Recall notice |
| 11/27/2023 | Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections | Recall notice |
| 11/17/2023 | 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 | Recall notice |
| 11/16/2023 | Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device | Recall notice |
| 11/15/2023 | Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing | Recall notice |
| 11/15/2023 | Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages | Recall notice |
| 11/14/2023 | Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in Manufacturing | Recall notice |
| 11/13/2023 | Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products | Recall notice |
| 11/06/2023 | Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling | Recall notice |
| 10/30/2023 | Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation | Recall notice |
| 10/24/2023 | Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds | Recall notice |
| 10/20/2023 | Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards | Recall notice |
| 10/18/2023 | Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits | Recall notice |
| 09/20/2023 | Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile | Recall notice |
| 09/13/2023 | Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode | Recall notice |
| 09/12/2023 | Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly | Recall notice |
| 08/31/2023 | Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops | Recall notice |
| 08/31/2023 | Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops | Recall notice |
| 08/31/2023 | Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures | Recall notice |
| 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 | Recall notice |
| 08/30/2023 | Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Notice | Recall notice |
| 08/23/2023 | Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath | Recall notice |
| 08/17/2023 | Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots | Recall notice |
| 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 | Recall notice |
| 08/14/2023 | 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 | Recall notice |
| 08/10/2023 | Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns | Recall notice |
| 07/31/2023 | 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 | Recall notice |
| 07/28/2023 | GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings | Recall notice |
| 07/27/2023 | Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent | Recall notice |
| 07/26/2023 | Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism | Recall notice |
| 07/18/2023 | 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 | Recall notice |
| 07/17/2023 | Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns | Recall notice |
| 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 | Recall notice |
| 07/14/2023 | NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates | Recall notice |
| 07/13/2023 | Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop | Recall notice |
| 07/11/2023 | Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients | Recall notice |
| 06/26/2023 | Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage | Recall notice |
| 06/12/2023 | BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use | Recall notice |
| 06/05/2023 | Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support | Recall notice |
| 05/25/2023 | SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination | Recall notice |
| 05/24/2023 | Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support | Recall notice |
| 05/22/2023 | 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 | Recall notice |
| 04/19/2023 | Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment | Recall notice |
| 04/07/2023 | Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy | Recall notice |
| 04/06/2023 | 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 | Recall notice |
| 03/31/2023 | Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss | Recall notice |
| 3/17/2023 | Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure | Recall notice |
| 03/13/2023 | Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds | Recall notice |
| 02/16/2023 | 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 | Recall notice |
| 02/15/2023 | GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients | Recall notice |
| 02/08/2023 | Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA | Recall notice |
| 02/02/2023 | Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy | Recall notice |
| 01/30/2023 | Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect | Recall notice |
| 01/27/2023 | LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure | Recall notice |
| 01/25/2023 | Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential | Recall notice |
| 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 | Recall notice |