CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report

Lifepak 20e recalled by Physio-Control

Physio-Control is recalling Lifepak 20e, distributed in West Virginia. The recall was initiated on 3 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Quantity recalled1

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-1232-2025
FDA event ID: 96095
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Feb 2025
FDA classified: 25 Feb 2025
Reported: 5 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Feb 2025	Recall initiated by company
25 Feb 2025	Classified by FDA	+22 days
5 Mar 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

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Product as listed by the FDA

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Where it was distributed

U.S.: WV O.U.S.: N/A

West Virginia

Questions about this recall

Is Lifepak 20e recalled?

Yes. Physio-Control recalled Lifepak 20e on 3 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1232-2025.

Why was it recalled?

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Which lots are affected?

Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

Where was it sold?

U.S.: WV O.U.S.: N/A

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