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Recalls

A list of FDA Recalls that is updated daily. It references medical equipment and medical product notifications and recalls. 

109 topics in this forum

  1. IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug

    By FDA Recalls,
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    • 59 views

  2. 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

    By FDA Recalls,
    • 0 replies
    • 66 views

  3. 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

    By FDA Recalls,
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    • 74 views

  4. Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

    By FDA Recalls,
    • 0 replies
    • 66 views

  5. 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

    By FDA Recalls,
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    • 76 views

  6. Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

    By FDA Recalls,
    • 0 replies
    • 80 views

  7. Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

    By FDA Recalls,
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    • 78 views

  8. Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns

    By FDA Recalls,
    • 0 replies
    • 93 views

  9. Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

    By FDA Recalls,
    • 0 replies
    • 63 views

  10. Related Recalls - Plastic Syringes Made in China for Potential Device Failures

    By FDA Recalls,
    • 0 replies
    • 62 views

  11. Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

    By FDA Recalls,
    • 0 replies
    • 95 views

  12. 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

    By FDA Recalls,
    • 0 replies
    • 64 views

  13. 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 Fau

    By FDA Recalls,
    • 0 replies
    • 77 views

  14. Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

    By FDA Recalls,
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    • 70 views

  15. Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

    By FDA Recalls,
    • 0 replies
    • 65 views

  16. FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur - Drug Safety Communication

    By FDA Recalls,
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    • 108 views

  17. Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators

    By FDA Recalls,
    • 0 replies
    • 68 views

  18. Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion

    By FDA Recalls,
    • 0 replies
    • 101 views

  19. 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

    By FDA Recalls,
    • 0 replies
    • 89 views

  20. Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® Tracheostomy Tubes

    By FDA Recalls,
    • 0 replies
    • 47 views

  21. 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

    By FDA Recalls,
    • 0 replies
    • 85 views

  22. Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction

    By FDA Recalls,
    • 0 replies
    • 143 views

  23. OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC

    By FDA Recalls,
    • 0 replies
    • 146 views

  24. Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter

    By FDA Recalls,
    • 0 replies
    • 135 views

  25. Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use

    By FDA Recalls,
    • 0 replies
    • 107 views
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