Guilford, CT, United States
Defibtech, LLC recalls
6 recalls recorded since 2018, most recently on 18 March 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 18 March 2025
- Reason
- 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 all three official languages of Switzerland (German, French, and Italian).
- Distribution
- International Only: Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1690-2025, Z-1691-2025, Z-1693-2025, Z-1692-2025
- Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
- Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(Fr
Ongoing Class II Medical devices
- Recall started
- 18 March 2025
- Reason
- 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 all three official languages of Switzerland (German, French, and Italian).
- Distribution
- OUS only: Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1694-2025
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Ongoing Class II Medical devices
- Recall started
- 14 October 2024
- Reason
- 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 potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
- Distribution
- Ireland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0504-2025, Z-0503-2025, Z-0502-2025, Z-0505-2025
- Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
- Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
- Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
- Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA
Ongoing Class I Medical devices
- Recall started
- 12 July 2024
- Reason
- 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.
- Distribution
- Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2543-2024
- RMU-2000 Automated Chest Compression Device
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1312-2023
- DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Terminated Class II Medical devices
- Recall started
- 27 April 2020
- Terminated
- 8 January 2021
- Reason
- A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2394-2020, Z-2392-2020, Z-2393-2020
- DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 0081
- DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN
- DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.