HeartSine — Class II medical device recall Z-2143-2023
Ongoing recall by HeartSine Technologies Ltd, reported 2023-07-19, distributed nationwide. Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which coul
| Recall number | Z-2143-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, N/A, United Kingdom |
| Recall initiated | 2023-04-26 |
| Classified | 2023-07-13 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DK, ES, FR, GB, IE, IL, IS, IT, JP, KR, NL, NZ, PE, PL, SG, TH, ZA |
| Quantity | 30,022 units |
| UPC / GTIN / UDI-DI | 05060167120466, 05060167120800, 05060167121234, 05060167121371, 05060167121418, 05060167121517, 05060167121593, 05060167121630, 05060167122453, 05060167122514, 05060167122606, 05060167122712, 05060167124525, 05060167124747, 05060167124754, 05060167125751, 05060167125812, 05060167125836, 05060167125843, 05060167125997, 05060167126444, 05060167127663, 05060167128028 |
| Lot numbers | 350-BAS-AS-10, 350-BAS-CF-10, 350-BAS-CN-10, 350-BAS-JA-08, 350-BAS-KO-10, 350-BAS-MS-10, 350-BAS-UK-10, 350-BAS-USROW-10, 360-BAS-AS-10, 360-BAS-CN-10, 360-BAS-KO-10/A3660, 360-BAS-SJ-10, 360-BAS-UK-10, 450-BAS-JA-08, 500-BAS-AS-10, 500-BAS-CF-10, 500-BAS-CN-10, 500-BAS-KO-10, 500-BAS-TH-10, 500-BAS-UK-10, A3632, A3633, A3634, A3635, A3636, A3637, A3638, A3639, A3640, A3641, A3642, A3643, A3644, A3646, A3652, A3653, A3654, A3655, A3656, A3657 and 90 more |
| Model numbers | 350P/360P/450P/500P, CE0123, PAD-PAK-01, PAD-PAK-03, PAD-PAK-03J |
Product
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
Reason for recall
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.
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-2143-2023. 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.