HeartSine Pad-Pak — Class II medical device recall Z-0288-2026
Ongoing recall by HeartSine Technologies Ltd, reported 2025-10-29, distributed nationwide. Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and ele
| Recall number | Z-0288-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartSine Technologies Ltd, Belfast, United Kingdom |
| Recall initiated | 2025-09-18 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IS, IT, JO, JP, KR, KW, LT, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 1,291,165 units |
| UPC / GTIN / UDI-DI | 00506016712123, 00506016712475 |
| Lot numbers | H017-002-071, H017-002-173, H017-002-174, H017-002-178, H023-002-009, H023-002-050, H023-002-051, H047-002-035, H047-002-100, H047-002-101 |
| Model numbers | PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-03J, PAD-PAK-04, PAD-PAK-04J, PAD-PAK-07 |
Product
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
Reason for recall
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
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-0288-2026. 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.