Medical Device Recalls

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
07/16/2025	Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly	Cranial Drill	Recall Confirmed
07/15/2025	Early Alert: Infusion Set Performance Issue from BD	Infusion Set	Early Alert - FDA Collecting Information
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	Early Alert - FDA Collecting Information
06/30/2025	Early Alert: Infusion Pump Software Issue from Baxter	Infusion Pump	Early Alert - FDA Collecting Information
06/30/2025	Early Alert: Blood Pump Controller Issue from Abiomed	Blood Pump Controller	Early Alert - FDA Collecting Information
06/25/2025	Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation	Angiographic Catheter	Recall Confirmed
06/24/2025	Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic	Esophageal pH Monitoring Capsule	Early Alert - FDA Collecting Information
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
04/18/2025	Early Alert: Intravascular PICC Catheter Issue from BD	Intravascular Catheter	Early Alert - FDA Collecting Information
04/18/2025	Early Alert: Diagnostic Intravascular Catheter Issue from Conavi	Intravascular Catheter	Early Alert - FDA Collecting Information
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
03/20/2025	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
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

• What is a Medical Device Recall?
• Recalls, Corrections and Removals (Devices)
• Medical Device Recalls Database
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program