LIFEPAK 15 — Class II medical device recall Z-2065-2026
Ongoing recall by Physio-Control, Inc., reported 2026-05-13, distributed nationwide. Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence
| Recall number | Z-2065-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2026-04-13 |
| Classified | 2026-05-04 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 206 |
| Model numbers | 99335-000013, 99335-000031, 99425-000023, 99425-000025, 99425-000096, 99507-000122, 99577-000025, 99577-000045, 99577-000047, 99577-001217, 99577-001219, 99577-001241, 99577-001255, 99577-001256, 99577-001372, 99577-001588, 99577-001935, 99577-001938, 99577-001950, 99577-001955, 99577-001956, 99577-001957, 99577-001958, 99577-001962, 99577-001964 and 1 more |
Product
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
Reason for recall
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
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-2065-2026. 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.