Class II — Maquet Cardiopulmonary Ag
| Recalling firm | Maquet Cardiopulmonary GmbH |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. |
| Product | Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. |
| Quantity | US: 2 units; OUS: 168 units |
| Distribution | Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand. |
| Initiated | 2025-04-30 |
| Classified | 2025-05-27 |
| Recall number | Z-1823-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiopulmonary Ag (Z-1823-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96820/
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