Physio-Control, Inc. recalls LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-0000…

Recall date

July 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2498-2025

FDA classification

Class II

Brand / firm

Physio-Control, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.