Recall database

Nuwellis Inc recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class ICompletedZ-0831-2025

Nuwellis Inc recalls nuwellis AquaFlexFlow UF 500 Plus

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.…

High Permeability With Or Without Sealed Dialysate System Dialyzer
Under Investigation by firm

Nuwellis IncMNJan 22, 2025