Recall Register

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HeartSine Technologies Ltd

FDA recalling firm · 7 enforcement events · 7 product records · 2023–2026 · N/A

HeartSine Technologies Ltd has 7 FDA enforcement events on this register (7 product records) between 2023 and 2026: 7 device; the busiest year was 2023 with 2.

0% of its events are Class I; the most common class is Class II (7). 7 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
27 Jul 2026HeartSine 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 US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI…DeviceClass II1Ongoing
18 Sep 2025HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04JDeviceClass II1Ongoing
30 Jun 2025HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)DeviceClass II1Ongoing
8 Apr 2024HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450PDeviceClass II1Ongoing
14 Feb 2024HeartSine 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; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10DeviceClass II1Ongoing
26 Apr 2023HeartSine, 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/500PDeviceClass II1Ongoing
1 Feb 2023Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR AdvisorDeviceClass II1Ongoing

By type and class

Device7
Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

23
24
25
26
Enforcement events for HeartSine Technologies Ltd by year initiated.

Questions and answers

How many FDA recalls has HeartSine Technologies Ltd had?

7 enforcement events (7 product records) on this register, 2023–2026: 7 device.

Are any HeartSine Technologies Ltd recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are HeartSine Technologies Ltd recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.