Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
2008 Series Hemodialysis Machines: 2008K with the following product code Recalled by Fresenius Medical Care Holdings, Inc. Due to The Acetate value for GranuFlo on the Select...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.
Affected Products
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Quantity: 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
Why Was This Recalled?
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report