| 12/23/2024 | Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus | Endoscope Accessory | Early Alert - FDA collecting information |
| 12/20/2024 | Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use | Infusion Pumps | Recall Confirmed |
| 12/20/2024 | Early Alert: Nephroscope Sheath Issue from Trokamed GmbH | Nephroscope Sheath | Early Alert - FDA collecting information |
| 12/18/2024 | Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula | Balloon Catheter | Recall Confirmed |
| 12/18/2024 | Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications | Implantable Radiographic Marker | Recall Confirmed |
| 12/11/2024 | Early Alert: Infusion Pump Issue from Fresenius Kabi USA | Infusion Pumps | Early Alert - FDA collecting information |
| 12/06/2024 | Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure | Neonatal Incubator | Recall Confirmed |
| 12/04/2024 | Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors | Syringes | Recall Confirmed |
| 11/29/2024 | Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs | Hemodialysis | Recall Confirmed |
| 11/29/2024 | Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs | Peritoneal Dialysis Set | Recall Confirmed |
| 11/29/2024 | Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm | Insertion Tube | Recall Confirmed |
| 11/29/2024 | Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle | Biopsy Needle | Recall Confirmed |
| 11/19/2024 | Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure | Anesthesia Machine | Recall Confirmed |
| 11/19/2024 | Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2, due to Risk of Inaccurate Flow Measurements Caused by Certain In-Line Nebulizer Placements | Ventilator | Recall Confirmed |
| 11/19/2024 | Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge | Battery Pack | Recall Confirmed |
| 11/15/2024 | Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel | Endoscopic Vessel Harvesting System | Recall Confirmed |
| 11/1/2024 | IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure | IPV Therapy | Recall Confirmed |
| 10/31/2024 | Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury | Incubator/Warmer | Recall Confirmed |
| 10/29/2024 | Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results | Air Compressor | Recall Confirmed |
| 10/25/2024 | Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk | Assistive Arm | Recall Confirmed |
| 10/25/2024 | Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon | Tracheostomy Tube | Recall Confirmed |
| 10/24/2024 | Ventilator Correction: Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm | Ventilator | Recall Confirmed |
| 10/18/2024 | Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding | Vascular Embolization | Recall Confirmed |
| 10/17/2024 | Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life | Insulin Pump | Recall Confirmed |
| 10/11/2024 | Infusion Pump Recall: Zyno Medical Removes Certain Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients | Infusion Pump | Recall Confirmed |
| 10/7/2024 | Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation | Resuscitator | Recall Confirmed |
| 10/2/2024 | IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug | IPV Therapy | Recall Confirmed |
| 10/1/2024 | Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation | Ventilator Software | Recall Confirmed |
| 10/1/2024 | Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy | Infusion Pump | Recall Confirmed |
| 9/30/2024 | Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement | Ventilator | Recall Confirmed |
| 9/24/2024 | Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components | Compounding Device | Recall Confirmed |
| 9/20/2024 | Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector | Ventilator | Recall Confirmed |
| 9/18/2024 | Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation | Tracheostomy Tube | Recall Confirmed |
| 9/17/2024 | Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm | Infusion Pump | Recall Confirmed |
| 9/16/2024 | Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets | Infusion Pump | Recall Confirmed |
| 9/5/2024 | Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings | Continuous Glucose Monitoring (CGM) Sensor | Recall Confirmed |
| 9/5/2024 | Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators | Ventilator | Recall Confirmed |
| 9/5/2024 | Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion | Laryngoscope | Recall Confirmed |
| 9/4/2024 | Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation | Lung Therapy | Recall Confirmed |
| 8/23/2024 | Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli | Clot Removal | Recall Confirmed |
| 8/23/2024 | Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail | Convenience Kit | Recall Confirmed |
| 8/22/2024 | Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions | Chest Compression Device | Recall Confirmed |
| 8/20/2024 | Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery | Infusion Pump | Recall Confirmed |
| 8/12/2024 | Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections | Heart Pump | Recall Confirmed |
| 8/6/2024 | Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for False Negative Response | Nerve Monitoring System | Recall Confirmed |
| 8/6/2024 | Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software due to Multiple Issues Related to Outdated Software | Ambulatory Infusion Pump | Recall Confirmed |
| 7/15/2024 | Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility | Eye Injection Kit | Recall Confirmed |
| 7/15/2024 | Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle | Ventilator | Recall Confirmed |
| 7/11/2024 | Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns | Electrode Pad | Recall Confirmed |
| 7/11/2024 | Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart | Ventilator | Recall Confirmed |
| 7/8/2024 | An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions | Implantable Hypoglossal Nerve Stimulator | Recall Confirmed |
| 7/8/2024 | Radiofrequency (RF) Coils Correction: Philips North America LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury | Radiofrequency (RF) Coils | Recall Confirmed |
| 6/28/2024 | Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy | Ventilator | Recall Confirmed |
| 6/28/2024 | Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop | Left Ventricular Assist System (LVAS) Monitor | Recall Confirmed |
| 6/27/2024 | Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure | Ventilator | Recall Confirmed |
| 6/27/2024 | Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy | BiPAP | Recall Confirmed |
| 6/13/2024 | Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients | Electrode Pad | Recall Confirmed |
| 6/13/2024 | Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride | Vaporizer | Recall Confirmed |
| 6/13/2024 | Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm | Catheter Kit | Recall Confirmed |
| 6/11/2024 | Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube | Endrotracheal Tube | Recall Confirmed |
| 6/5/2024 | Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery | Software | Recall Confirmed |
| 5/30/2024 | OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC | Infusion Pump | Recall Confirmed |
| 5/23/2024 | Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use | Tube | Recall Confirmed |
| 5/22/2024 | Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices | Implantable Radiographic Marker | Recall Confirmed |
| 5/15/2024 | Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff | Ventricular Assist System | Recall Confirmed |
| 5/13/2024 | Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction | Ventilators | Recall Confirmed |
| 5/10/2024 | Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band | Catheter | Recall Confirmed |
| 5/8/2024 | Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion | Mobile App | Recall Confirmed |
| 4/30/2024 | BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations | Test | Recall Confirmed |
| 4/29/2024 | SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty | Sensor | Recall Confirmed |
| 4/29/2024 | SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip | Monitor | Recall Confirmed |
| 4/26/2024 | Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle | Biopsy Needle | Recall Confirmed |
| 4/25/2024 | InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death | Infusion Pump | Recall Confirmed |
| 4/25/2024 | Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power | Anesthesia System | Recall Confirmed |
| 4/25/2024 | Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs | Hemodialysis System | Recall Confirmed |
| 4/25/2024 | Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA | Catheter Extension | Recall Confirmed |
| 4/24/2024 | DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist | General Surgery Tray | Recall Confirmed |
| 4/17/2024 | Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death | Software | Recall Confirmed |
| 4/17/2024 | Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding | Embolic Agent | Recall Confirmed |
| 4/14/2024 | Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction | Ventricular Assist System | Recall Confirmed |
| 4/4/2024 | Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft | Catheter | Recall Confirmed |
| 4/4/2024 | 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 | Ventilator Kit | Recall Confirmed |
| 4/3/2024 | 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 | Catheter Kit | Recall Confirmed |
| 3/25/2024 | Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist | Kits and Trays | Recall Confirmed |
| 3/21/2024 | Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death | Resuscitator | Recall Confirmed |
| 3/21/2024 | Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks | Blood Pump | Recall Confirmed |
| 3/14/2024 | Avanos Recalls MIC Gastric - Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist | Feeding Tube Kit | Recall Confirmed |
| 3/11/2024 | Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop | Monitor | Recall Confirmed |
| 3/11/2024 | 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 | Lower Extremity Pack | Recall Confirmed |
| 3/7/2024 | Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap | Breathing Pack | Recall Confirmed |
| 3/7/2024 | 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 | Catheter | Recall Confirmed |
| 3/6/2024 | Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error | Software | Recall Confirmed |
| 3/5/2024 | Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions | Syringe Pump | Recall Confirmed |
| 2/29/2024 | Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch | Incubator | Recall Confirmed |
| 2/15/2024 | Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling | Imaging System | Recall Confirmed |
| 2/14/2024 | Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions | Syringe Pump | Recall Confirmed |
| 2/6/2024 | Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization | Breathing Circuit Kit | Recall Confirmed |
| 1/31/2024 | Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist | Chest Drain | Recall Confirmed |
| 1/30/2024 | Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error | Fluoroscopy | Recall Confirmed |
| 1/16/2024 | ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility | Surgical Kit | Recall Confirmed |
| 1/12/2024 | Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference | Pump | Recall Confirmed |
| 1/11/2024 | ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices | CPAP | Recall Confirmed |
| 1/11/2024 | Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist | Trays and Kits | Recall Confirmed |
| 1/8/2024 | Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns | Electrode | Recall Confirmed |
| 1/8/2024 | Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error | Software | Recall Confirmed |
