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High risk Medical DevicesClass II

Physio-Control LIFEPAK Defibrillator Recall 2026

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-00193

Updated April 13, 2026

Physio-Control is recalling certain LIFEPAK defibrillators that were serviced between July 2023 and November 2025 without confirmed completion of a required Performance Inspection Procedure. A defibrillator that hasn't been properly inspected may fail to deliver therapy when it's needed most, potentially delaying or preventing life-saving treatment.

Is the Physio-Control, Inc. recalled? Yes. This product was recalled by FDA on April 13, 2026. Details below.

What is recalled

Physio-Control LIFEPAK defibrillators across four models, identified by the following REF numbers: • 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 Affected units are those serviced between July 2023 and November 2025.

Am I affected

You are affected if you own or operate a Physio-Control LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, or LIFEPAK 20e defibrillator that matches one of the REF numbers listed above AND was serviced between July 2023 and November 2025. Check the device label or service records for the REF number and the most recent service date to determine whether your unit is included.

What to do right now

Stop relying on any affected device as your sole source of defibrillation until its service status has been verified. Because this recall was initiated by Physio-Control and no consumer contact number was provided in the recall record, contact Physio-Control (now part of Stryker) directly through their official website or your authorized service representative to confirm whether your specific unit is affected and to arrange a proper Performance Inspection. If you are a healthcare facility or first-responder agency, notify your biomedical/equipment team immediately.

The hazard

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.

Brands affected

Physio-Control, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2065-2026
Classification
Class II
Recalled
April 13, 2026
Read the official notice

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