Cardiohelp System HKH 8820 Wall Holder — Class II medical device recall Z-1823-2025
Ongoing recall by Maquet Cardiopulmonary Ag, reported 2025-06-04, distributed in IL, MO. HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
| Recall number | Z-1823-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiopulmonary Ag, Rastatt, N/A, Germany |
| Recall initiated | 2025-04-30 |
| Classified | 2025-05-27 |
| Reported by FDA | 2025-06-04 |
| Distributed | IL, MO |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, HR, IL, IN, IT, JP, KR, PL, RU, SA, TH |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04037691456584 |
| Model numbers | 701045366 |
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Reason for recall
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
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-1823-2025. 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.