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 |