Drug & Device Safety Atlas
Class II FDA device recall · Z-2497-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

Why it was recalled

Due to required inspections not being performed on products/units that have gone through servicing.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information
Part / Catalog Numbers / UDI-DI code / Serial Number: V15-7-000022  / 99577-001957 / 883873871690 / 49085553  V15-2-000051 / 99577-000046 / 883873988022 / 38154524  V15-2-000099 / 99577-000093 / 883873979020 / 39059475  V15-2-001603 / 99577-001256 / 883873911631 / 40973093

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

U.S. Nationwide distribution in the states of CO and MT.

Recall record

Recalling firm
Physio-Control, Inc.
Product type
Devices
Recall number
Z-2497-2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
N/A
Origin
Redmond, WA
Recall initiated
2025-07-22

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2497-2025 · Source: openFDA enforcement.