CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report

Lifepak 15 Part recalled by Physio-Control

Physio-Control is recalling Lifepak 15 Part, distributed nationwide in the US. The recall was initiated on 22 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart / 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

Quantity recalled4 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2497-2025
FDA event ID: 96949
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Jul 2025
FDA classified: 2 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Processing Deviation
Device type: Patient Monitors

Timeline

22 Jul 2025	Recall initiated by company
2 Sep 2025	Classified by FDA	+42 days
10 Sep 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Colorado Montana

Questions about this recall

Is Lifepak 15 Part recalled?

Yes. Physio-Control recalled Lifepak 15 Part on 22 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2497-2025.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Physio-Control

All 36

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak CR2 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
5 Mar 2025Device	CLASS II	Lifepak 20e recalled by Physio-Control	Physio-Control	Other	WV

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
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