Lower riskMedical device recall · FDA · Published July 27, 2022
Fresenius Medical Care 2008T Hemodialysis Machines Recall: False USB Alerts Due to EMI
Fresenius Medical Care recalls 2008T and 2008TBluestar hemodialysis machines with CDX software versions 2.72 or earlier that may show false 'Remove USB 2 Device' alerts due to electromagnetic interference.
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
“Fresenius Medical Care 2008T Hemodialysis Machines Recall: False USB Alerts Due to EMI.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60303-fresenius-medical-care-2008t-hemodialysis-machines-recall-false-usb-alerts. Based on FDA recall #Z-0734-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2023%22&limit=1).
The FDA announced on July 27, 2022, that Fresenius Medical Care Holdings, Inc. is recalling 2008T and 2008TBluestar Hemodialysis Machines with CDX due to a software version 2.74 upgrade and hardware issue causing false alarms. The agency stated the devices are sensitive to electromagnetic interference.
How to tell if you have it
Brand: Fresenius Medical Care
Models: 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX; 191124 2008T HD SYS. CDX BLUESTAR; 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
Quantity: 2008T with CDX= 70,552; 2008T Bluestar with CDX= 25,205
The hazard
According to the FDA, a software version 2.74 upgrade and a hardware-related cause affecting only CDX Machines has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI). This sensitivity will cause the false alarm "Remove USB 2 Device".
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since 2014-04-14. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk (2026-05-12), Fresenius 5008X Blood Tubing Set Recall (2026-05-11), and Fresenius Medical Care Bicarby Dialysate Recall (2026-05-07). Additional recent recalls include Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall (2026-06-30), Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (2026-07-29), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (2026-08-10).
How to tell if you have this one
Check for model numbers 190713, 190766, 191124, or 191126 on the machine. The software version should be 2.72 or earlier. The recall applies to machines sold with CDX-Indicated for acute and chronic dialysis therapy.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the machine; if it is 2.72 or earlier, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0734-2023 (July 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0734-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.