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LIFEPAK recallZ-2499-2025 · Physio-Control, Inc. · initiated Jul 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-2499-2025
Status
Open, Classified
Initiated by the company
Jul 22, 2025
Posted by the FDA
Sep 2, 2025
Recalling firm
Physio-Control, Inc.
Quantity
1 unit
Product code
MKJ
FDA submissions
P170018
Distribution
U.S. Nationwide distribution in the states of CO and MT.

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

11 devices cleared under P170018 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96949).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page