FDA Device recall Z-1823-2025
Cardiohelp System HKH 8820 Wall Holder
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Cardiohelp System HKH 8820 Wall Holder by Maquet Cardiopulmonary Ag, citing HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-30 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Cardiopulmonary Ag |
| Distribution | IL, MO |
Product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Reason
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Identifiers
| code_info | Model No. 701045366; UDI 04037691456584; All Serial No. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2025%22
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