Recall archive / FDA device enforcement
Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG... — FDA record Z-0504-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.)
- 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
- Classification
- Class II
- Recalling firm
- Defibtech, LLC
- Quantity
- 22,294 total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0504-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00815098020447, DDP-2001 adult defibrillation pads, single pack; 30815098020448, DDP-2001 adult defibrillation pads, 10 pairs; 50815098020442, DDP-2001 adult defibrillation pads, 40 pairs |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Ireland
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 4, 2024
- Recall initiation date
- Oct 14, 2024
- Center classification date
- Nov 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.