Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report: 12/17/2025
Class: II

PRODUCT

Recall Number:

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Fresenius Medical Care Holdings, Inc.

VOLUME:

115 units

DISTRIBUTION:

Domestic: LA, MA, MN;