FDA recall record · openFDA

Defibtech, LLC

11 FDA recalls on record (2023–2025) — 11 device. 11 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance 5

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibt 3

A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a 1

Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the devi 1

Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech A 1

Recalls

RMU-2000 Automated Chest Compression Device Class I 2024-07-12 Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D Class II 2025-03-18 Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22 Class II 2025-03-18 Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) Class II 2025-03-18 Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22 Class II 2025-03-18 Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310 Class II 2025-03-18 Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, Class II 2024-10-14 Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Serie Class II 2024-10-14 Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indi Class II 2024-10-14 Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline E Class II 2024-10-14 DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest Class II 2023-02-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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