| Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation |
10/07/2024 |
| IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug |
10/02/2024 |
| Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation |
10/01/2024 |
| Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy |
10/01/2024 |
| Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement |
09/30/2024 |
| Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components |
09/24/2024 |
| Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector |
09/20/2024 |
| Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation |
09/18/2024 |
| Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm |
09/17/2024 |
| Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets |
09/16/2024 |
| Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings |
09/05/2024 |
| Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators |
09/05/2024 |
| Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion |
09/05/2024 |
| Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation |
09/04/2024 |
| Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli |
08/23/2024 |
| Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail |
08/23/2024 |
| Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions |
08/22/2024 |
| Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery |
08/20/2024 |
| Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections |
08/12/2024 |
| Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for False Negative Response |
08/06/2024 |
| Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software due to Multiple Issues Related to Outdated Software |
08/06/2024 |
| Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility |
07/15/2024 |
| Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle |
07/15/2024 |
| Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns |
07/11/2024 |
| Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart |
07/11/2024 |
| An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions |
07/08/2024 |
| Radiofrequency (RF) Coils Correction: Philips North America LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury |
07/08/2024 |
| Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy |
06/28/2024 |
| Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop |
06/28/2024 |
| Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure |
06/27/2024 |
| Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy |
06/27/2024 |
| Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients |
06/13/2024 |
| Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride |
06/13/2024 |
| Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm |
06/13/2024 |
| Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube |
06/11/2024 |
| Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery |
06/05/2024 |
| OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC |
05/30/2024 |
| Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use |
05/23/2024 |
| Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices |
05/22/2024 |
| Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff |
05/15/2024 |
| Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction |
05/13/2024 |
| Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band |
05/10/2024 |
| Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion |
05/08/2024 |
| BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations |
04/30/2024 |
| SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty |
04/29/2024 |
| SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip |
04/29/2024 |
| Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle |
04/26/2024 |
| InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death |
04/25/2024 |
| Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power |
04/25/2024 |
| Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs |
04/25/2024 |
| Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA |
04/25/2024 |
| DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist |
04/24/2024 |
| Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death |
04/17/2024 |
| Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding |
04/17/2024 |
| Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction |
04/14/2024 |
| Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft |
04/04/2024 |
| Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation |
04/04/2024 |
| Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage |
04/03/2024 |
| Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist |
03/25/2024 |
| Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death |
03/21/2024 |
| Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks |
03/21/2024 |
| Avanos Recalls MIC Gastric - Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist |
03/14/2024 |
| Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop |
03/11/2024 |
| Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile Water Based Products Under Recall by Nurse Assist |
03/11/2024 |
| Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap |
03/07/2024 |
| Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock Connectors |
03/07/2024 |
| Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error |
03/06/2024 |
| Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions |
03/05/2024 |
| Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators |
03/01/2024 |
| Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch |
02/29/2024 |
| Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling |
02/15/2024 |
| Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions |
02/14/2024 |
| Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization |
02/06/2024 |
| Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist |
01/31/2024 |
| Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error |
01/30/2024 |
| ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility |
01/16/2024 |
| Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference |
01/12/2024 |
| ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices |
01/11/2024 |
| Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist |
01/11/2024 |
| Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns |
01/08/2024 |
| Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error |
01/08/2024 |
