CLASS III Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

HeartSine Samaritan PAD, SAM 350P Semi-Automatic recalled

Physio-Control is recalling HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak, distributed in Alaska. The recall was initiated on 13 Jan 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesGTIN/UDI: 05060167120695, Serial Number: 20D00009694

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-0745-2022
FDA event ID: 89536
Recalling firm: Physio-Control, Redmond, WA
Classification: Class III
Status: Terminated
Recall initiated: 13 Jan 2022
FDA classified: 10 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

13 Jan 2022	Recall initiated by company
10 Mar 2022	Classified by FDA	+56 days
16 Mar 2022	Published in enforcement report	+6 days

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

Reason for recall

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

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

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Where it was distributed

U.S.: AK

Alaska

Questions about this recall

Why was it recalled?

Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

Which lots are affected?

GTIN/UDI: 05060167120695, Serial Number: 20D00009694

Where was it sold?

U.S.: AK

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from Physio-Control

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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

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