LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451… — Class II medical device recall Z-2499-2025
Ongoing recall by Physio-Control, Inc., reported 2025-09-10, distributed nationwide. Due to required inspections not being performed on products/units that have gone through servicing.
| Recall number | Z-2499-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2025-07-22 |
| Classified | 2025-09-02 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00883873785911 |
| Serial numbers | 49638156, 883873785911, 99512-001434, CR2-2-001451 |
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.
Reason for recall
Due to required inspections not being performed on products/units that have gone through servicing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2499-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.