FDA recall, , Moderate risk
Fresenius Medical Care 2008T BlueStar Hemodialysis Machine
The 2008T BlueStar Hemodialysis Machine has received complaints about flow-, no water-, or temperature-related alarms.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care Renal Therapies Group, LLC, located in Waltham, Massachusetts, has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis Machine. The company began the recall on June 30, 2026, and it was added to the FDA's Enforcement Report on August 26, 2026, with nationwide distribution.
The recall involves 1140 systems and was classified by the FDA on August 26, 2026. The product was included in the FDA's weekly enforcement report on September 2, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
2008T BlueStar Hemodialysis Machine
- Model number
- 191126
- 191130
- UDI-DI
- 00840861102099
- 00840861102112
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Fresenius Medical Care Renal Therapies Group, LLCWaltham, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99438
- Recall number
- Z-3017-2026
- Quantity recalled
- 1140 systems
All recalls from Fresenius Medical Care Renal Therapies Group, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
