Physio-Control, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2498-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 22, 2025

Date Posted: September 10, 2025

Recall Number: Z-2498-2025

Event ID: 96949

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3 units

Code Information:

Part / Catalog Numbers / UDI-DI code / Serial Number: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated