High FDA (Devices)·Z-3017-2026·Announced 2026-09-02

Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects

Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (hemodialysis machine) with reported functional defects (alarms) that could compromise patient safety, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 1,140 units of the 2008T BlueStar Hemodialysis Machine, specifically model numbers 191126 and 191130. The recall covers systems distributed nationwide in the United States.

The recall was initiated after the company received complaints regarding flow-, no water-, or temperature-related alarms on the affected machines. These alarms indicate potential issues with the machine's ability to properly monitor or control the dialysis process.

Healthcare facilities and consumers with these specific model numbers should stop using the machines and contact Fresenius Medical Care for instructions on repair or replacement. The recall number is Z-3017-2026.

The recalled product

Product: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Category: Medical Device — Hemodialysis Machine
Hazard: malfunction
alarm-failure
Affected units: 1,140

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

191126
UDI/DI 00840861102099
Serial Numbers: 5T0S291116
5T0S291119
5T0S291125
5T0S291135
5T0S291137
5T0S291138
5T0S291139
5T0S291140
5T0S291141
5T0S291143
5T0S291144
5T0S291145
5T0S291146
5T0S291148
5T0S291149
5T0S291150
5T0S291151
5T0S291152

Distribution

Distributed nationwide across the United States.

Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC

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Same hazard · malfunction