Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0936-2026)

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:

5008X CAREsystem +CLiC +CDX;

Product Classification:

Class II

Date Initiated: October 25, 2025

Date Posted: December 24, 2025

Recall Number: Z-0936-2026

Event ID: 97934

Reason for Recall:

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Status: Ongoing

Product Quantity: 115 units

Code Information:

Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Distribution Pattern:

Domestic: LA, MA, MN;

Voluntary or Mandated:

Voluntary: Firm initiated