# FDA recall Z-2498-2025

> **Physio-Control, Inc.** · Class II · device recall initiated 2025-07-22.

## Product

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code:  320371500023 / 99425-000025 / 885074698953  320371500229 / 99425-000025 / 885074698953  331706400001 / 99425-000025 / 885074698953      LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation.  ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

## Reason for recall

Due to required inspections not being performed on products/units that have gone through servicing.

## Distribution

U.S. Nationwide distribution in the states of CO and MT.

## Key facts

- **Recall number:** Z-2498-2025
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-22
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2025

## Citation

> AI Analytics. FDA recall Z-2498-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-2498-2025. Source: US FDA. Licensed CC0.

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