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Physio-Control LIFEPAK Defibrillators
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MEDICAL DEVICE RECALLMODERATE

Physio-Control LIFEPAK Defibrillators

Physio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.

What to do

Contact your local Physio-Control representative or the company's technical support department to arrange for a formal performance inspection of your device.

Recalled
Listed
Updated
Recall No.
Z-2065-2026
Agency
FDA
Firm
Physio-Control, Inc.
Recall ID
98418
Status
ONGOING

Why it was recalled

Physio-Control is recalling various LIFEPAK defibrillator models serviced between July 2023 and November 2025. These devices were serviced without objective evidence that a Performance Inspection Procedure was conducted, which may result in delays or an inability to provide life-saving therapy.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
0088387387168

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification