# FDA recall Z-2065-2026

> **Physio-Control, Inc.** · Class II · device recall initiated 2026-04-13.

## 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.

## Distribution

US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.

## Key facts

- **Recall number:** Z-2065-2026
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-13
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2065-2026

## Citation

> AI Analytics. FDA recall Z-2065-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2065-2026. Source: US FDA. Licensed CC0.

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