CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report

Lifepak 15, REF: 99577-001958, Part Number: V15 recalled

Physio-Control is recalling Lifepak 15, REF: 99577-001958, Part Number: V15-7-000023, distributed nationwide in the US. The recall was initiated on 29 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00883873871683/ Serial number: 48839976

Quantity recalled1 unit

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-0304-2024
FDA event ID: 93233
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 29 Sep 2023
FDA classified: 14 Nov 2023
Reported: 22 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

29 Sep 2023	Recall initiated by company
14 Nov 2023	Classified by FDA	+46 days
22 Nov 2023	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

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023

Where it was distributed

US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

Nationwide Arizona California North Carolina New Jersey New York

Questions about this recall

Is Lifepak 15, REF: 99577-001958, Part Number: V15-7-000023 recalled?

Yes. Physio-Control recalled Lifepak 15, REF: 99577-001958, Part Number: V15-7-000023 on 29 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0304-2024.

Why was it recalled?

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Which lots are affected?

UDI: 00883873871683/ Serial number: 48839976

Where was it sold?

US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

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 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

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide