Z-2499-2025Class II

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The...

Name: Z-2499-2025 LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The...
Creator: Physio-Control, Inc.
Published: 2025-07-22
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2025-07-22 / Open, Classified

FDA source

Physio-Control, Inc. began a recall of 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... on 2025-07-22. FDA classified it as Class II and gives the reason as "Due to required inspections not being performed on products/units that have gone through servicing". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2499-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-22
Posted: 2025-09-02
Recalling firm: Physio Control, Inc.
Product: 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 code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Due to required inspections not being performed on products/units that have gone through servicing.
FDA root cause: Under Investigation by firm
Action: On 07/22/2025, the firm sent via certified mail an "URGENT: Medical device recall" Letter to customers informing them that, Stryker discovered a subset of work orders performed between August 10th 2022 and October 30th 2023 with Performance Inspection Procedures (PIP) recorded as PASS without the corresponding objective evidence properly documented in the work order to ensure the devices are performing as intended. Customers are instructed to: 1. Immediately check their inventory to locate the affected product as listed in the letter. 2. On the business reply form, customer need to indicate if their devices have been serviced since October 30th 2023 (after that time, if affected device have undergone Preventative Maintenance through Stryker, Stryker has verified that the PIPs were completed and passed in accordance with the required standards. For these devices No additional action is required. 3. Return business reply form. Upon receipt, Stryker will contact customers to arrange for corrective action on the device if service has not been performed. 4. There are no additional actions that users can and should take. Continue to follow the Operating Instructions and perform the daily checks and user tests. Tests can be found in the chapter "Maintaining the Equipment' subsection "General Maintenance and Testing" For Questions or concerns, contact Customer Service at +1 800 787-9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time, Monday thru Friday or email [email protected]
Quantity in commerce: 1 unit
Distribution: U.S. Nationwide distribution in the states of CO and MT.
Product codes and lots: Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2499-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2497-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2498-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02
Z-2499-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-02

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)