Skip to content
Lower risk Medical device recall · FDA · Published March 12, 2020

Fresenius 2008T Hemodialysis Machine: False USB Alert May Appear

Fresenius recalls 2008T hemodialysis machines with specific part numbers due to false USB device alerts when no device is connected. No action needed as it's a false alarm.

🇺🇸 FDA recall #Z-1748-2020Medical deviceFresenius ›
Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius is recalling certain 2008T hemodialysis machines that may show a false 'Remove USB Device 2' alert when no USB device is connected. This is a false alarm and does not affect safety or function. Read more at govinfonow.com/recall/65660-fresenius-2008t-hemodialysis-machine-false-usb-alert-may-appear.

Source Summary by GovInfoNow · govinfonow.com/recall/65660-fresenius-2008t-hemodialysis-machine-false-usb-alert-may-appear · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1748-2020

Cite this page

“Fresenius 2008T Hemodialysis Machine: False USB Alert May Appear.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65660-fresenius-2008t-hemodialysis-machine-false-usb-alert-may-appear. Based on FDA recall #Z-1748-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1748-2020%22&limit=1).

Why it’s dangerous

The machine may display a false alert when no USB device is connected to its rear port. This is a software glitch that does not cause harm or disrupt dialysis treatment.

Who’s affected

Hemodialysis patients and healthcare providers using the 2008T model with specific part numbers. Those most at risk are users who rely on the machine's alerts for critical functions.

How to tell if you have this one

Check the part numbers listed: 190573, 190713, 190766, 190858, 190895, 190908. These models were sold with specific serial numbers and configurations.

  • Brand
    Fresenius
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide Foreign: Canada, Curaca, Guam
Recall numberProduct, codes & lotsQuantity
Z-1748-2020Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN; All serial numbers101,463
Z-1749-2020Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR; All serial numbers15,342
Based on the official FDA remedy

What to do — step by step

  1. Check for False Alert

    Look for the 'Remove USB Device 2' message when no USB device is connected to the machine's rear port.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Canada, Curaca, Guam” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Mar 12, 202012. FDA classified it Class II: Apr 20, 202023. Published in FDA’s Enforcement Report: Apr 29, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Fresenius recalls

Latest medical device recalls

Keep exploring

Where this comes from

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-1748-2020 (March 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1748-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA