---
title: "HeartSine Technologies Ltd Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall"
description: "Search HeartSine Technologies Ltd recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions."
url: https://isitonrecall.com/brand/heartsine-technologies-ltd/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Home](https://isitonrecall.com/) / Brand archive

# HeartSine Technologies Ltd recall records

**7** reported ongoing

7 records in this archive. Latest source date Jul 27, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## Records and reported status

Jul 27, 2026 FDA device enforcement

### [HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P ...](https://isitonrecall.com/recall/fda-device-z-3120-2026-heartsine-sam-350p-350p-us-device-us-english-2-min-cpr-udi-di-codes-0506016712067-350p-us-device-us/)

Due to a damaged (over stretched) membrane tail that causes an intermittent fault.

Class II Reported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR...

[Official source for HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Dev...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3120-2026%22)

Sep 18, 2025 FDA device enforcement

### [HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J](https://isitonrecall.com/recall/fda-device-z-0288-2026-heartsine-pad-pak-ref-pad-pak-01-pad-pak-02-pad-pak-03-pad-pak-04-pad-pak-07-pad-pak-03j-pad-pak-04j/)

Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

Class II Reported ongoing

Distribution: US Nationwide distribution. Worldwide distribution to Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republ...

[Official source for HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0288-2026%22)

Jun 30, 2025 FDA device enforcement

### [HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)](https://isitonrecall.com/recall/fda-device-z-2174-2025-heartsine-sam-350p-heartsine-sam-360p-and-heartsine-sam-450p-the-heartsine-samaritan-pad-public-acce/)

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Class II Reported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N...

[Official source for HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Publ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2174-2025%22)

Apr 8, 2024 FDA device enforcement

### [HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P](https://isitonrecall.com/recall/fda-device-z-1820-2024-heartsine-samaritan-pad-public-access-defibrillator-type-sam-350p-sam-360p-sam-450p/)

Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially l...

Class II Reported ongoing

Distribution: US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC,...

[Official source for HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1820-2024%22)

Feb 14, 2024 FDA device enforcement

### [HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10;...](https://isitonrecall.com/recall/fda-device-z-1141-2024-heartsine-samaritan-pad-public-access-defibrillator-type-catalog-sam-350p-350-unit-us-10-350-str-us/)

Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instr...

Class II Reported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.

[Official source for HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1141-2024%22)

Apr 26, 2023 FDA device enforcement

### [HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P](https://isitonrecall.com/recall/fda-device-z-2143-2023-heartsine-ref-pad-pak-01-pad-pak-03-and-pad-pak-03j-ce0123-sold-separately-and-with-the-heartsine-sa/)

Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

Class II Reported ongoing

Distribution: Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, ...

[Official source for HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the Heart...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2143-2023%22)

Feb 1, 2023 FDA device enforcement

### [Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor](https://isitonrecall.com/recall/fda-device-z-1217-2023-heartsine-samaritan-pad-sam-350p-semi-automatic-defibrillator-sam-360p-fully-automatic-defibrillator/)

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

Class II Reported ongoing

Distribution: US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand

[Official source for Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibril...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1217-2023%22)

## Reasons in these listed records

- Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
- Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
- Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or...

These examples come from this result page and are not a ranking of every recall reason.

## Checking HeartSine Technologies Ltd

### Is there a recall on heartsine technologies ltd right now?

This archive contains 7 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

### How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier.

### Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

### What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices.

### Where can I find older records?

Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

## Keep checking

[Search HeartSine Technologies Ltd](https://isitonrecall.com/check/?q=HeartSine%20Technologies%20Ltd) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)
