# FDA recall Z-0502-2025

> **Defibtech, LLC** · Class II · device recall initiated 2024-10-14.

## Product

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)

## Reason for recall

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 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

## Key facts

- **Recall number:** Z-0502-2025
- **Recalling firm:** Defibtech, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-14
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2025

## Citation

> AI Analytics. FDA recall Z-0502-2025. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0502-2025. Source: US FDA. Licensed CC0.

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