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RecallWatchMedical Device Safety
Class IIOngoingZ-3017-2026

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care

Fresenius Medical Care Renal Therapies Group, LLCWaltham, MA, United StatesReported Sep 2, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126191130
    400 affected lots
    5T0S2911165T0S2911195T0S2911255T0S2911355T0S2911375T0S2911385T0S2911395T0S291140
    +392 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

What the firm is doing

Fresenius Medical Care issued an URGENT MEDICAL DEVICDE CORRECTION notice to its consignees on 7/15/2026 via USPS First Class Mail. The notice explained the issue, potential risk and requested the following: "What to do at this time: 1. If your affected 2008T BlueStar machine is in use, and you are not experiencing error messages, you may continue to use it until the parts are replaced. 2. If your affected 2008T BlueStar machine experiences flow-, no water-, or temperature-related alarms, please use a back-up machine until FMCRTG can replace the parts in the affected machine. 3. If your affected 2008T BlueStar machine(s) has not yet been installed at your clinic, FMCRTG will replace the parts before installation. To correct your machine(s), please contact FMCRTG Technical Service between 8:00 AM 5:00 PM Eastern daily, at 1-800-227-2572, and select Option 4, followed by Option 2, to be connected with the appropriate support representative to schedule your update, or if you have any further questions." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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