Physio-Control, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2499-2025)

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 CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

Product Classification:

Class II

Date Initiated: July 22, 2025

Date Posted: September 10, 2025

Recall Number: Z-2499-2025

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: 1 unit

Code Information:

Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated