Nuwellis Inc: Medical Device Recall in 2025 - (Recall #: Z-0831-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

Product Classification:

Class I

Date Initiated: December 11, 2024

Date Posted: January 22, 2025

Recall Number: Z-0831-2025

Event ID: 95991

Reason for Recall:

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.

Status: Completed

Product Quantity: 845 units

Code Information:

Lot Numbers: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, 22740.

Distribution Pattern:

US Nationwide Distribution and the country of Hong Kong

Voluntary or Mandated:

Voluntary: Firm initiated