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Medical Device Recalls and Early Alerts

Update – September 29, 2025

CDRH is expanding the Communications Pilot to Enhance the Medical Device Recall Program to include all medical devices. See the What is an Early Alert? webpage for additional information. 

The FDA lists the most serious type of medical device recalls, as well as early alert communications about corrective actions being taken by companies that the FDA believes are likely to be the most serious type of recalls, on our website by the date that the FDA posts the information on our website. The FDA will keep the public informed and update our website as significant new information becomes available.

Recent Medical Device Recalls and Early Alerts

DateIssueProduct AreaStatus
2/05/2026Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil SystemDetachable Coil System    Recall Confirmed
02/04/2026Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 PlusContinuous Glucose Monitor SensorRecall Confirmed
02/03/2026Early Alert: Heart Pump Issue from AbiomedHeart PumpEarly Alert – FDA Collecting Information
01/22/2026Early Alert: Wound and Burn Dressing Issue from Integra LifeSciencesWound and Burn DressingEarly Alert – FDA Collecting Information
01/22/2026Early Alert: Insufflation Unit Issue from OlympusInsufflation UnitEarly Alert – FDA Collecting Information
01/16/2026Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific StentEarly Alert - FDA Collecting Information
01/16/2026Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 VaporizersAnesthetic Vaporizer    Recall Confirmed
01/16/2026Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit KitsAnesthesia Kit Recall Confirmed
01/16/2026Early Alert: Broselow Rainbow Tape Issue from AirLifeBroselow Rainbow TapeEarly Alert - FDA Collecting Information
01/14/2026Early Alert: Dialysis Tubing Set Issue from VantiveDialyzer AccessoryEarly Alert - FDA Collecting Information
01/09/2026Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery KitsConvenience Kit 
01/05/2026Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System PlatformsInfusion Pump SoftwareRecall Confirmed
01/05/2026Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery DevicesEsophageal pH Monitoring CapsuleRecall Confirmed
01/05/2026Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid CathetersDiagnostic Intravascular Catheter Recall Confirmed
01/05/2026Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular CathetersIntravascular PICC Catheter Recall Confirmed
01/05/2026Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration SystemsAspiration SystemRecall Confirmed
01/05/2026Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume PumpsInfusion PumpRecall Confirmed
01/02/2026Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure PacksCustom Surgical PackRecall Confirmed
12/30/2025Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette SetIntravascular Administration SetRecall Confirmed
12/29/2025Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro
Software
Continuous Glucose Monitoring SoftwareRecall Confirmed
12/23/2025Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts  Catheter MountRecall Confirmed
12/23/2025Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft Endovascular GraftsRecall Confirmed
12/23/2025System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SVMRI SystemsRecall Confirmed
12/23/2025Early Alert: Convenience Kit Needle Issue from Integra LifeSciencesConvenience KitEarly Alert - FDA Collecting Information
12/29/2025Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia SystemsAnesthesia SystemsRecall Confirmed
12/03/2025Correction Alert: Olympus Updates Use Instructions for Ligating Device    Esophageal LigatorRecall Confirmed
12/01/2025Recall Alert: Glycar SA Removes Pericardial PatchIntracardiac PatchRecall Confirmed
11/28/2025Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump IssueInfusion PumpsRecall Confirmed
11/26/2025Recall Alert: BALT USA Removes MEGA Ballast Distal Access PlatformVentilator SystemsRecall Confirmed
11/26/2025Alert: Baxter Permanently Removes Life2000 Ventilation SystemVentilator SystemsRecall Confirmed
11/25/2025Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist DevicesWheelchair Power AssistRecall Confirmed
11/21/2025Recall Alert: Intersurgical Inc Removes i-View Video LaryngoscopeLaryngoscopeRecall Confirmed
11/21/2025Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope HandlesMedical Convenience KitRecall Confirmed
11/20/2025Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing FluctuationsNitric Oxide Delivery SystemRecall Confirmed
11/20/2025Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input IssueNitric Oxide Delivery SystemRecall Confirmed
11/20/2025Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience KitsConvenience KitsRecall Confirmed
11/19/2025Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems3T MRI SystemsRecall Confirmed
11/19/2025Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing SetBlood TubingRecall Confirmed
10/10/2025Alert: Automated Impella Controller Correction due to Cybersecurity Issue from AbiomedAutomated Impella ControllerRecall Confirmed
09/26/2025Update on Early Alert: Infusion Set Performance Issue from BD      Infusion SetRecall Confirmed
09/24/2025Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming SystemBlood and Plasma Warming DevicesRecall Confirmed
09/24/2025Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic TipsBronchoscope AccessoryRecall Confirmed
09/23/2025Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Purge Retainer IssuesCatheter ControllersRecall Confirmedn
09/18/2025Ablation Catheter Correction: Abbott Updates Use Instructions for TactiFlex Ablation CatheterAblation CathetersRecall Confirmed
09/16/2025Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks due to a Firmware ErrorElectrical Wheelchair ComponentsRecall Confirmed
09/16/2025Convenience Kits Recall: Medline Removes Kits that May Contain Recalled Medtronic Cardiac CannulasCardiac Cannula    Recall Confirmed
09/15/2025Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin DeliveryInsulin PumpRecall Confirmed
09/12/2025Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor FailureGlucose MonitorsRecall Confirmed
09/12/2025Update on Alert: Defibrillation Lead Issue from Boston ScientificDefibrillation SystemsRecall Confirmed
09/12/2025Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy ModesVentilatorsRecall Confirmed
08/29/2025Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into PlaceHeart Pump AccessoryRecall Confirmed
08/29/2025Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact VentilationBreathing Circuit SetsRecall Confirmed
08/29/2025Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer PortResuscitatorsRecall Confirmed
08/28/2025Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit BoardVentilatorsRecall Confirmed
08/28/2025Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin ConcernsApplicatorsRecall Confirmed
08/28/2025Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming UnresponsiveInfusion PumpRecall Confirmed
08/27/2025Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Pump Driver Circuit Assembly IssuesCathetersRecall Confirmed
08/22/2025Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device WithdrawalVascular StentRecall Confirmed
12/22/2025Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent CatheterCardiac CannulaRecall Confirmed
08/15/2025Infusion Pumps Correction: Baxter Issues Correction for Novum IQ Infusion PumpsInfusion PumpRecall Confirmed
08/12/2025Recall: Draeger Removes SafeStar and TwinStar Filters due to Risk of Misleading Carbon Dioxide (CO₂) ReadingsBreathing System FiltersRecall Confirmed
08/06/2025Vascular Access Systems Correction: Boston Scientific Updates Use Instructions for WATCHMAN Access Systems
 
Vascular and Transseptal Access SystemsRecall Confirmed
08/06/2025Early Alert: Electrophysiology Catheter Issue from Medline ReNewalElectrophysiology CathetersEarly Alert - FDA Collecting Information
08/04/2025Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of TherapyContinuous VentilatorRecall Confirmed
07/25/2025Disposable Surgical Stapler Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical ProceduresDisposable Surgical StaplersRecall Confirmed
07/24/2025Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire ExposureArterial CannulaRecall Confirmed
07/23/2025Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper AttachmentMobile Lift ComponentRecall Confirmed
12/22/2025Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume PumpsInfusion PumpRecall Confirmed
07/22/2025Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device DisassemblyMedical Procedure KitsRecall Confirmed
07/21/2025Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal PatientsContinuous VentilatorRecall Confirmed
07/21/2025Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns        Piston SyringeRecall Confirmed
07/18/2025Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V FilterManual ResuscitatorRecall Confirmed
07/17/2025Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar LevelsContinuous Glucose MonitorRecall Confirmed
07/17/2025Portable Oxygen Concentrator Car Adapter Recall: Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter Due to Cord Possibly Becoming Hot to the Touch and/or Melting While Being UsedOxygen ConcentratorRecall Confirmed
12/22/2025Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension SetsMicrobore Extension SetRecall Confirmed
07/16/2025Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device DisassemblyCranial DrillRecall Confirmed
07/10/2025Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-SterilityClosed Suction CatheterRecall Confirmed
07/09/2025Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During VentilationInfant Breathing SystemRecall Confirmed
07/09/2025Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted InformationPediatric Emergency Rainbow TapeRecall Confirmed
12/22/2025Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella ControllersBlood Pump ControllerRecall Confirmed
06/25/2025Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip SeparationAngiographic CatheterRecall Confirmed
06/23/2025Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure CodeResuscitation SystemRecall Confirmed
06/23/2025Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male LuersMedical Procedure Kits Recall Confirmed
06/23/2025Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective VentilationAnesthesia Delivery SystemRecall Confirmed
06/17/2025Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Set due to Incorrect AssemblyBlood Products Administration SetRecall Confirmed
06/17/2025Convenience Kit Recall: Medline Neonatal and Pediatric Kits Containing Smiths Medical ORAL/NASAL Endotracheal Tubes due to Unexpectedly Smaller Tube DiameterNeonatal and Pediatric Convenience KitsRecall Confirmed
06/17/2025Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System, Cheetah Delivery ToolAspiration CatheterRecall Confirmed
06/16/2025Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software IssueInfusion PumpRecall Confirmed
06/13/2025Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to DelaminationIOPS GuidewireRecall Confirmed
06/13/2025Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to ContaminationLiquid Bicarbonate ConcentrateRecall Confirmed
06/05/2025Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device CannulaTube tracheostomy and tube cuffRecall Confirmed
06/05/2025Anesthesia Breathing Circuit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Risk of Inadequate Ventilation from Cracked HosesAnesthesia Breathing Circuit KitsRecall Confirmed
06/05/2025Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for UnderinfusionInfusion PumpRecall Confirmed
06/03/2025False Alarm Issue with Infusion Pump from Smiths MedicalInfusion PumpRecall Confirmed
06/03/2025Infusion Pump Thermal Damage Issue from Smiths MedicalInfusion PumpRecall Confirmed
06/03/2025Infusion Pump Intermittent Connection Issue from Smiths MedicalInfusion PumpRecall Confirmed
05/23/2025Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber LumenEsophagogastric TubeRecall Confirmed
04/24/2025Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power LossHeart Pump AccessoryRecall Confirmed
03/31/2025Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male LuerAortic CannulaRecall Confirmed
03/25/2025Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause UnderventilationEndotracheal TubeRecall Confirmed
03/20/2025Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load Infusion Pump SoftwareRecall Confirmed
03/19/2025Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation  Implantable PortRecall Confirmed
03/18/2025Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid DeformationEmbolization DeviceRecall Confirmed
03/20/2025Update on  Alert: Infusion Pump Issue from Baxter Healthcare Corporation Infusion PumpRecall Confirmed
03/03/2025Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove ImplantEndovascular SystemRecall Confirmed
03/03/2025Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen FluorideVaporizerRecall Confirmed
02/28/2025Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic AttackAblation CatheterRecall Confirmed
02/28/2025Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned MattressesPatient TableRecall Confirmed
02/28/2025Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the UserControl DialRecall Confirmed
02/28/2025Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller SpringResuscitatorRecall Confirmed
02/28/2025Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures Sheath KitRecall Confirmed
02/21/2025Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device ReplacementPacemakerRecall Confirmed
02/14/2025Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or RemovalHeart PumpRecall Confirmed
02/10/2025Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume FlowBreathing CircuitRecall Confirmed
02/06/2025Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May DetachCatheter KitRecall Confirmed
03/20/2025Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral VascularAtherectomy Catheter SystemRecall Confirmed
02/05/2025Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fireOxygen ConcentratorRecall Confirmed
02/05/2025Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperableVentilatorRecall Confirmed
02/03/2025Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks  Monitoring SystemRecall Confirmed
01/31/2025Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective VentilationResuscitator Recall Confirmed
01/30/2025Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient ResultsGlucose Strip/MeterRecall Confirmed
03/05/2025Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USAInfusion Pump SoftwareRecall Confirmed
07/15/2025Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During UseEndoscopic Vessel Harvesting (EVH) SystemRecall Confirmed
01/13/2025Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient CareMobile Cardiac Telemetry MonitoringRecall Confirmed
03/05/2025Update on Alert: Solution Set Issue from Baxter Healthcare CorporationSolution SetsRecall Confirmed
01/31/2025Update to Alert: Fluid Delivery Set Issue from MedlineFluid Delivery SetRecall Confirmed
01/31/2025Update to Alert: Extracorporeal Blood Circuit Issue from NuwellisSingle Use Blood CircuitRecall Confirmed
01/31/2025Update to Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from OlympusEndoscope AccessoryRecall Confirmed
12/20/2024Infusion 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 UseInfusion PumpsRecall Confirmed
01/31/2025Update to Alert: Nephroscope Sheath Issue from Trokamed GmbHNephroscope SheathRecall Confirmed
12/18/2024Catheter 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 FistulaBalloon CatheterRecall Confirmed
12/18/2024Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient ComplicationsImplantable Radiographic MarkerRecall Confirmed
01/31/2025Update to Alert: Infusion Pump Issue from Fresenius Kabi USAInfusion PumpsRecall Confirmed

Additional Resources



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