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1. Home
2. Medical Devices
3. Medical Device Safety
4. Medical Device Recalls and Early Alerts
1. Medical Device Safety
In this section
* Medical Device Recalls and Early Alerts
+ What is a Medical Device Recall?
+ What is an Early Alert?
+ Recall and Alert Resources
Medical Device Recalls and Early Alerts
* Medical Device Recalls and Early Alerts
+ What is a Medical Device Recall?
+ What is an Early Alert?
+ Recall and Alert Resources
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
Date Issue Product Area Status
05/05/2026 Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads Surgical Stapler Recall Confirmed
05/05/2026 Sizing Catheter Recall: Cook Medical Removes Various Centimeter Sizing Catheters Sizing Catheter Recall Confirmed
04/28/2026 Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems Blood Glucose Monitor Recall Confirmed
04/28/2026 Early Alert: Thoracic Stent Graft Issue from Bolton Medical Thoracic Stent Graft Early Alert – FDA collecting information
04/24/2026 Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers Dialysis Catheter Kit Early Alert – FDA collecting information
04/24/2026 Early Alert: Automated Compounding System Issue from Omnicell Automated Compounding System Early Alert – FDA collecting information
04/23/2026 Early Alert: Convenience Kit Issue from Aligned Medical Solutions Convenience Kit Early Alert – FDA collecting information
04/22/2026 Hemodialysis Bloodline Set Correction: B. Braun Medical Inc. Issues Correction for Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines Bloodline Set Recall Confirmed
04/22/2026 Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps Insulin Pump Recall Confirmed
04/16/2026 Early Alert: Convenience Kit Issue from American Contract Systems Convenience Kit Early Alert – FDA collecting information
04/16/2026 Early Alert: Convenience Kit Issue from Medical Action Industries Convenience Kit Early Alert – FDA collecting information
04/15/2026 Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants Reconstruction Prosthesis Recall Confirmed
04/15/2026 Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators Ventilator Recall Confirmed
04/15/2026 Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve Ventilator Tubing Recall Confirmed
04/14/2026 Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL Anesthesia Workstation Recall Confirmed
04/14/2026 Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer Dialysis Catheter Recall Confirmed
04/10/2026 Early Alert: Convenience Kit Issue from AVID Medical Convenience Kit Early Alert – FDA Collecting Information
04/09/2026 Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits Ventilator Recall Confirmed
04/09/2026 Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes Angiographic Syringe Recall Confirmed
03/25/2026 Heating Pad Recall: Navajo Manufacturing Company Removes Handy Solutions Neck & Shoulders Heating Pad Heating Pad Recall Confirmed
04/29/2026 Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods Insulin Pump Recall Confirmed
03/25/2026 Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes Cryoprobe
03/06/2026 Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products Wound and Burn Dressing Recall Confirmed
03/05/2026 Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound CathetersEarly Electrophysiology Catheter and Ultrasound Catheter Recall Confirmed
03/05/2026 Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters Electrophysiology Catheter and Ultrasound Catheter Recall Confirmed
02/25/2026 Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software Infusion Pump Software Recall Confirmed
04/03/2026 Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes Heart Pump Recall Confirmed
02/13/2026 Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds Electronic Homecare Bed Recall Confirmed
02/05/2026 Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System Detachable Coil System Recall Confirmed
02/04/2026 Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitor Sensor Recall Confirmed
04/03/2026 Heart Pump Correction: Abiomed Updates Use Instructions for Impella RP with SmartAssist Devices Heart Pump Recall Confirmed
02/23/2026 Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units Insufflation Unit Recall Confirmed
02/25/2026 Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems Stent Recall Confirmed
01/16/2026 Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers Anesthetic Vaporizer Recall Confirmed
01/16/2026 Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits Anesthesia Kit Recall Confirmed
02/11/2026 Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers Broselow Rainbow Tape Recall Confirmed
03/16/2026 Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris Sets Dialyzer Accessory Recall Confirmed
01/09/2026 Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits Convenience Kit
01/05/2026 Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms Infusion Pump Software Recall Confirmed
01/05/2026 Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices Esophageal pH Monitoring Capsule Recall Confirmed
01/05/2026 Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters Diagnostic Intravascular Catheter Recall Confirmed
01/05/2026 Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters Intravascular PICC Catheter Recall Confirmed
01/05/2026 Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems Aspiration System Recall Confirmed
01/05/2026 Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps Infusion Pump Recall Confirmed
01/02/2026 Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs Custom Surgical Pack Recall Confirmed
12/30/2025 Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set Intravascular Administration Set Recall Confirmed
12/29/2025 Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Continuous Glucose Monitoring Software Recall Confirmed
Software
12/23/2025 Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts Catheter Mount Recall Confirmed
12/23/2025 Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft Endovascular Grafts Recall Confirmed
12/23/2025 System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV MRI Systems Recall Confirmed
03/16/2026 Convenience Kit Recall: Integra LifeSciences Removes Tuohy Needle Convenience Kit Recall Confirmed
12/29/2025 Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems Anesthesia Systems Recall Confirmed
12/03/2025 Correction Alert: Olympus Updates Use Instructions for Ligating Device Esophageal Ligator Recall Confirmed
12/01/2025 Recall Alert: Glycar SA Removes Pericardial Patch Intracardiac Patch Recall Confirmed
11/28/2025 Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue Infusion Pumps Recall Confirmed
11/26/2025 Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform Ventilator Systems Recall Confirmed
11/26/2025 Alert: Baxter Permanently Removes Life2000 Ventilation System Ventilator Systems Recall Confirmed
11/25/2025 Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices Wheelchair Power Assist Recall Confirmed
11/21/2025 Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope Laryngoscope Recall Confirmed
11/21/2025 Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles Medical Convenience Kit Recall Confirmed
11/20/2025 Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations Nitric Oxide Delivery System Recall Confirmed
11/20/2025 Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue Nitric Oxide Delivery System Recall Confirmed
11/20/2025 Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits Convenience Kits Recall Confirmed
11/19/2025 Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems 3T MRI Systems Recall Confirmed
11/19/2025 Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set Blood Tubing Recall Confirmed
10/10/2025 Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed Automated Impella Controller Recall Confirmed
09/26/2025 Update on Early Alert: Infusion Set Performance Issue from BD Infusion Set Recall Confirmed
09/24/2025 Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System Blood and Plasma Warming Devices Recall Confirmed
09/24/2025 Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips Bronchoscope Accessory Recall Confirmed
09/23/2025 Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Purge Retainer Issues Catheter Controllers Recall Confirmedn
09/18/2025 Ablation Catheter Correction: Abbott Updates Use Instructions for TactiFlex Ablation Catheter Ablation Catheters Recall Confirmed
09/16/2025 Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks due to a Firmware Error Electrical Wheelchair Components Recall Confirmed
09/16/2025 Convenience Kits Recall: Medline Removes Kits that May Contain Recalled Medtronic Cardiac Cannulas Cardiac Cannula Recall Confirmed
09/15/2025 Insulin 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 Delivery Insulin Pump Recall Confirmed
09/12/2025 Continuous 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 Failure Glucose Monitors Recall Confirmed
09/12/2025 Update on Alert: Defibrillation Lead Issue from Boston Scientific Defibrillation Systems Recall Confirmed
09/12/2025 Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes Ventilators Recall Confirmed
08/29/2025 Mobile 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 Place Heart Pump Accessory Recall Confirmed
08/29/2025 Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation Breathing Circuit Sets Recall Confirmed
08/29/2025 Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port Resuscitators Recall Confirmed
08/28/2025 Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board Ventilators Recall Confirmed
08/28/2025 Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns Applicators Recall Confirmed
08/28/2025 Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive Infusion Pump Recall Confirmed
08/27/2025 Catheter Controller Recall: Abiomed Removes Automated Impella Controllers due to Pump Driver Circuit Assembly Issues Catheters Recall Confirmed
08/22/2025 Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal Vascular Stent Recall Confirmed
12/22/2025 Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter Cardiac Cannula Recall Confirmed
08/15/2025 Infusion Pumps Correction: Baxter Issues Correction for Novum IQ Infusion Pumps Infusion Pump Recall Confirmed
08/12/2025 Recall: Draeger Removes SafeStar and TwinStar Filters due to Risk of Misleading Carbon Dioxide (CO₂) Readings Breathing System Filters Recall Confirmed
08/06/2025 Vascular Access Systems Correction: Boston Scientific Updates Use Instructions for WATCHMAN Access Systems Vascular and Transseptal Access Systems Recall Confirmed
08/04/2025 Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy Continuous Ventilator Recall Confirmed
07/25/2025 Disposable Surgical Stapler Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical Procedures Disposable Surgical Staplers Recall Confirmed
07/24/2025 Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure Arterial Cannula Recall Confirmed
07/23/2025 Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment Mobile Lift Component Recall Confirmed
12/22/2025 Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps Infusion Pump Recall Confirmed
07/22/2025 Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly Medical Procedure Kits Recall Confirmed
07/21/2025 Continuous 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 Patients Continuous Ventilator Recall Confirmed
07/21/2025 Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns Piston Syringe Recall Confirmed
07/18/2025 Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter Manual Resuscitator Recall Confirmed
07/17/2025 Continuous 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 Levels Continuous Glucose Monitor Recall Confirmed
07/17/2025 Portable 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 Used Oxygen Concentrator Recall Confirmed
12/22/2025 Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets Microbore Extension Set Recall Confirmed
04/23/2026 Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly Cranial Drill Recall Confirmed
07/10/2025 Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility Closed Suction Catheter Recall Confirmed
07/09/2025 Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation Infant Breathing System Recall Confirmed
07/09/2025 Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information Pediatric Emergency Rainbow Tape Recall Confirmed
12/22/2025 Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers Blood Pump Controller Recall Confirmed
06/25/2025 Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation Angiographic Catheter Recall Confirmed
06/23/2025 Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code Resuscitation System Recall Confirmed
06/23/2025 Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers Medical Procedure Kits Recall Confirmed
06/23/2025 Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation Anesthesia Delivery System Recall Confirmed
06/17/2025 Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Set due to Incorrect Assembly Blood Products Administration Set Recall Confirmed
06/17/2025 Convenience Kit Recall: Medline Neonatal and Pediatric Kits Containing Smiths Medical ORAL/NASAL Endotracheal Tubes due to Unexpectedly Smaller Tube Diameter Neonatal and Pediatric Convenience Kits Recall Confirmed
06/17/2025 Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System, Cheetah Delivery Tool Aspiration Catheter Recall Confirmed
06/16/2025 Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue Infusion Pump Recall Confirmed
06/13/2025 Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination IOPS Guidewire Recall Confirmed
06/13/2025 Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination Liquid Bicarbonate Concentrate Recall Confirmed
06/05/2025 Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula Tube tracheostomy and tube cuff Recall Confirmed
06/05/2025 Anesthesia Breathing Circuit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Risk of Inadequate Ventilation from Cracked Hoses Anesthesia Breathing Circuit Kits Recall Confirmed
06/05/2025 Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion Infusion Pump Recall Confirmed
06/03/2025 False Alarm Issue with Infusion Pump from Smiths Medical Infusion Pump Recall Confirmed
06/03/2025 Infusion Pump Thermal Damage Issue from Smiths Medical Infusion Pump Recall Confirmed
06/03/2025 Infusion Pump Intermittent Connection Issue from Smiths Medical Infusion Pump Recall Confirmed
05/23/2025 Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen Esophagogastric Tube Recall Confirmed
04/24/2025 Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss Heart Pump Accessory Recall Confirmed
03/31/2025 Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer Aortic Cannula Recall Confirmed
03/25/2025 Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation Endotracheal Tube Recall Confirmed
03/20/2025 Infusion 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 Software Recall Confirmed
03/19/2025 Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation Implantable Port Recall Confirmed
03/18/2025 Embolization 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 Deformation Embolization Device Recall Confirmed
03/20/2025 Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation Infusion Pump Recall Confirmed
03/03/2025 Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant Endovascular System Recall Confirmed
03/03/2025 Vaporizer 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 Fluoride Vaporizer Recall Confirmed
02/28/2025 Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack Ablation Catheter Recall Confirmed
02/28/2025 Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses Patient Table Recall Confirmed
02/28/2025 Power 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 User Control Dial Recall Confirmed
02/28/2025 Regard 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 Spring Resuscitator Recall Confirmed
02/28/2025 Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures Sheath Kit Recall Confirmed
02/21/2025 Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement Pacemaker Recall Confirmed
02/14/2025 Heart 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 Removal Heart Pump Recall Confirmed
02/10/2025 Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow Breathing Circuit Recall Confirmed
02/06/2025 Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach Catheter Kit Recall Confirmed
03/20/2025 Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular Atherectomy Catheter System Recall Confirmed
02/05/2025 Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire Oxygen Concentrator Recall Confirmed
02/05/2025 Continuous 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 inoperable Ventilator Recall Confirmed
02/03/2025 Pressure 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 System Recall Confirmed
01/31/2025 Gas 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 Ventilation Resuscitator Recall Confirmed
01/30/2025 Glucose 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 Results Glucose Strip/Meter Recall Confirmed
03/05/2025 Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA Infusion Pump Software Recall Confirmed
07/15/2025 Endoscopic 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 Use Endoscopic Vessel Harvesting (EVH) System Recall Confirmed
01/13/2025 Outpatient 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 Care Mobile Cardiac Telemetry Monitoring Recall Confirmed
03/05/2025 Update on Alert: Solution Set Issue from Baxter Healthcare Corporation Solution Sets Recall Confirmed
01/31/2025 Update to Alert: Fluid Delivery Set Issue from Medline Fluid Delivery Set Recall Confirmed
01/31/2025 Update to Alert: Extracorporeal Blood Circuit Issue from Nuwellis Single Use Blood Circuit Recall Confirmed
01/31/2025 Update to Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus Endoscope Accessory Recall Confirmed
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
01/31/2025 Update to Alert: Nephroscope Sheath Issue from Trokamed GmbH Nephroscope Sheath Recall Confirmed
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
01/31/2025 Update to Alert: Infusion Pump Issue from Fresenius Kabi USA Infusion Pumps Recall Confirmed
Previous Recalls
* 2024 Medical Device Recalls
* 2023 Medical Device Recalls
* Previous recall listings from 2013 - 2022 (archived)
Additional Resources
* Recall and Alert Resources
* Content current as of:
05/05/2026
* Regulated Product(s)
+ Medical Devices
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