Update – November 21, 2024
CDRH announced a Communications Pilot to Enhance the Medical Device Recall Program to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. The pilot will include early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.
Through the Communications Pilot to Enhance the Medical Device Recall Program , the FDA has committed to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. However, the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.
The FDA will keep the public informed and update our website as significant new information becomes available.
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.
Recent Medical Device Recalls and Early Alerts Date Issue Product Area Status 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Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load Infusion Pump Software Recall Confirmed 03/20/2025 Early Alert: Aspiration System Issue from Calyxo Aspiration System Early Alert - FDA collecting information 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 01/15/2025 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
Additional Resources
Content current as of:
03/25/2025
