Defibtech recalls

5 official recalls and safety alerts involving Defibtech since 2023-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Defibtech or the relevant agency.

  1. 2025-05-07
  2. US
    Drugs & medicalClass II

    Defibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1…

    It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…

    FDA · DeviceDefibtech, LLCInternational Only: Switzerland.Official notice →
  3. 2024-12-04
  4. US
    Drugs & medicalClass II

    Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…

    Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could…

    FDA · DeviceDefibtech, LLCIrelandOfficial notice →
  5. US
    Drugs & medicalClass II

    Defibtech, LLC recalls Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…

    Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead…

    FDA · DeviceDefibtech, LLCIrelandOfficial notice →
  6. 2024-08-21
  7. US
    Drugs & medicalClass I

    Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device

    Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

    FDA · DeviceDefibtech, LLCDomestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to JapanOfficial notice →
  8. 2023-04-05
  9. US
    Drugs & medicalClass II

    Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

    A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

    FDA · DeviceDefibtech, LLCUS Nationwide distribution.Official notice →