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

Lifepak 1000 Part recalled by Physio-Control

Physio-Control is recalling Lifepak 1000 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: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273

Quantity recalled3 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-2498-2025
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: Pacemakers & Defibrillators

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 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Where it was distributed

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

Nationwide Colorado Montana

Questions about this recall

Is Lifepak 1000 Part recalled?

Yes. Physio-Control recalled Lifepak 1000 Part on 22 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2498-2025.

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: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273

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 15 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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