Recall Z-3017-2026— Fresenius Medical Care Renal Therapies Group, LLC

Name: FDA recall Z-3017-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2026-06-30. It names one FDA 510(k) clearance: K243237. Product: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.. Reason: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines..

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-06-30
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K243237 — 2008T HD SYS. CDX BLUESTAR (191124) +3 moreFresenius Medical Care Renal Therapies Group, LLC·cleared 2025-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Reason for recall

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Data sourced from openFDA. This site is unofficial and independent of the FDA.