Class I — Nuwellis Inc
| Recalling firm | Nuwellis, Inc. |
|---|---|
| Registered facility | Nuwellis, Inc. (the firm's only registered facility) |
| Classification | Class I |
| Status | Completed |
| Reason | The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients. |
| Product | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System |
| Quantity | 845 units |
| Distribution | US Nationwide Distribution and the country of Hong Kong |
| Initiated | 2024-12-11 |
| Classified | 2025-01-16 |
| Recall number | Z-0831-2025 |
| 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 I recall — Nuwellis Inc (Z-0831-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95991/
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