HeartSine SAM 350P 350P US Device — Class II medical device recall Z-3120-2026
Ongoing recall by HeartSine Technologies Ltd, reported 2026-09-16, distributed nationwide. Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
| Recall number | Z-3120-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, United Kingdom |
| Recall initiated | 2026-07-27 |
| Classified | 2026-09-04 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CL, CO, GB, HK, ID, IL, JP, KR, MY, NL, PH, PL, SG, TH, TW |
| Quantity | 11,912 |
| Serial numbers | 003935H23, 22D91164357L22, 22D91164989L22, 22D91165150L22, 22D91180808K23, 22G91037109D22, 22G91037113D22, 22G91037115D22, 22G91037234D22, 22G91037235D22, 22G91037238D22, 22G91037239D22, 23D98000415K23, 23D98000597K23, 23D98001134L23, 23D98001634I23, 23D98001722F23, 23D98002004K23, 23D98002054K23, 23D98002059I23, 23D98002086L23, 23D98002225K23, 23D98002639K23, 23D98002649K23, 23D98002771L23 and 475 more |
| Model numbers | 350-STR-AA-AV, 350-STR-US-10, 350-STR-US-GW, 350P, 360-STR-US-10, 360P, 450-STR-US-10, 450P |
Product
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 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 code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).
Reason for recall
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3120-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.