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  1. Medical Device Recalls

The list below contains recalls that were issued in 2024.

2024 Medical Device Recalls

Device Name Date
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



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