Defibtech Lifeline ECG AEDs Recalled for Potential Shock Delivery Failure
Defibtech is recalling 860 Lifeline ECG Automated External Defibrillators because a component issue may cause the device to abort or reset, potentially failing to deliver a shock.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a life-saving device failing to deliver a shock during cardiac arrest, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Defibtech, LLC is recalling 860 units of the DDU-2450 Lifeline ECG Automated External Defibrillator (AED). The affected models include DDU-A2450EN, DDU-E2450DE, DDU-E2450EN, DDU-E2450FR, and DDU-E2450TH, with catalog numbers DCF-A2460EN, DCF-A2463EN, DCF-E2460DE, DCF-E2460EN, DCF-E2460FR, and DCF-E2460TH. The devices are identified by specific serial numbers listed in the recall notice and UDI codes 00815098020287 and 00815098020317.
The recall is due to a component issue that may cause the AED to abort a shock delivery or reset unexpectedly. This malfunction could result in the device failing to deliver a shock or failing to deliver a shock within the required range. AEDs are indicated for use on victims of sudden cardiac arrest who are unconscious, unresponsive, and not breathing or not breathing normally.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, France, Malaysia, Mauritius, the Netherlands, Thailand, and the United Arab Emirates. Users should check their device serial numbers against the provided list to determine if their unit is affected.
The recalled product
- Product
- 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, 00815098020317 Automated External Defibrillators (AED) are indi
- Manufacturer
- Defibtech, LLC
- Affected units
- 860
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Defibtech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Defibtech, LLC
See all →- LowAutomated External Defibrillators DDU-2200 Missing Italian Language Translation
FDA (Devices) · 2025-05-07
- ModerateDefibtech Automated External Defibrillators Model DDU-2300 Recalled
FDA (Devices) · 2025-05-07
- LowDefibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation
FDA (Devices) · 2025-05-07
- ModerateAutomated External Defibrillator Model DDU-2450 Missing Italian Translation
FDA (Devices) · 2025-05-07
- LowSemi-Automated External Defibrillators Missing Italian Language Labeling
FDA (Devices) · 2025-05-07
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12