LIFEPAK CR2 (Physio-Control) – Inspection Failure (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 patien
Brand
Physio-Control, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156
Physio-Control, Inc. is recalling LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK C due to Due to required inspections not being performed on products/units that have gone through servicing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to required inspections not being performed on products/units that have gone through servicing.
Recommended Action
Per FDA guidance
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 medtechsup@stryker.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026