Nuwellis Inc
Nuwellis Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0831-2025, Class I) was initiated on December 11, 2024. Its most recent 510(k) clearance was granted on August 13, 2025.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0831-2025 | Class I | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit w | December 11, 2024 |