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

Lifepak 15, REF: 99577-001957, Part Number V15 recalled

Physio-Control is recalling Lifepak 15, REF: 99577-001957, Part Number V15-5-000586 and, 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: 00883873871690/ Serial number: 43393466 44142362 44739628 44742060 47821623 49025144 49663485 49887344

Quantity recalled8 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-0303-2024
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: 99577-001957, Part Number V15-5-000586 and V15-7-000022

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

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: 00883873871690/ Serial number: 43393466 44142362 44739628 44742060 47821623 49025144 49663485 49887344

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

Other products in this recall event

9 other products · FDA event 93233

This product is part of a recall event; the main page for the event is Lifepak 15, REF: 99577-000046, Part Number V15 recalled.

Reported	Class	Recall	Company	Reason	Where
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-000046, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-000061, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001960, Part Number: V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001373, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001956, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001255, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-000055, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001958, Part Number: V15 recalled	Physio-Control	Device Malfunction	Nationwide
22 Nov 2023	CLASS II	Lifepak 15, REF: 99577-001955, Part Number V15 recalled	Physio-Control	Device Malfunction	Nationwide

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 13,884

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7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide