2008 Series Hemodialysis Machines: 2008K2 with the following
Medical device recall Z-1552-2015. Published in FDA’s Enforcement Report on May 6, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0K0S-0678 0K0S-0885 0K0S-0901 0K0S-0917 0K0S-0922 0K0S-0927 0K0S-0935 0K0S-0943 0K0S-0959 0K0S-0960 0K0S-0963 0K0S-0992 0K0S149209-149999 0K0S150000- 152000 0K0S152001- 154000 0K0S154001- 160000 0K0S160001- 162000…
Every code shown here, 1,830 characters
Serial Numbers: 0K0S-0678 0K0S-0885 0K0S-0901 0K0S-0917 0K0S-0922 0K0S-0927 0K0S-0935 0K0S-0943 0K0S-0959 0K0S-0960 0K0S-0963 0K0S-0992 0K0S149209-149999 0K0S150000- 152000 0K0S152001- 154000 0K0S154001- 160000 0K0S160001- 162000 0K0S162001- 165353 0S154030 1K0S-1000 1K0S-1022 1K0S-1027 1K0S-1029 1K0S-1035 1K0S-1037 1K0S-1044- 1046 1K0S-1065 1K0S-1067 1K0S-1070 1K0S-1094 1K0S-1095 1K0S-1102 1K0S-1103 1K0S-1121 1K0S165354- 174103 2K0S174104 2K0S174105- 174111 2K0S174150- 182134 2K0S-5783 2K0S-5802 2K0S-6015 2K0S-6046 2K0S-6065 2K0S-6067 2K0S-6109 2K0S-6232 2K0S-6266 2K0S-9573 3K0S182135- 188639 4K0S188640- 192508 4K0S192542 4K0S192545 4K0S192550- 192553 4K0S192555 4K0S192566- 192569 4K0S192571 4K0S192572 4K0S192575- 192577 4K0S192579 4K0S192581 4K0S192584- 192586 4K0S192588 4K0S192593 4K0S192602 4K0S192603 4K0S192605 4K0S192675 4K0S192738- 192740 4K0S-N592 4K0S-Q302 4K0S-Q350 4K0S-Q362 4K0S-Q425 4K0S-Q467 4K0S-Q470 4K0S-Q502 5K0S-132B 5K0S-856B 5K0S-T230 5K0S-V420 5K0S-X901 5K0S-Y378 6K0S-029N 6K0S-151Q 6K0S-180Q 6K0S-205M 6K0S-239M 6K0S-255N 6K0S-315N 6K0S-331Q 6K0S-821G 6K0S-903R 6K0S-942S 7K0S103279 7K0S103983 7K0S104826 7K0S112150 7K0S112155 7K0S115550 8K0S118640 8K0S121287 8K0S122793 8K0S126296- 126305 8K0S126314- 126323 8K0S126573 8K0S128448 8K0S128506 8K0S129030- 129033 8K0S129211- 129321 8K0S129335 8K0S129337- 129339 8K0S129369 8K0S129431- 129435 8K0S129440 8K0S129447- 129490 8K0S129503- 129516 8K0S129893 8K0S130289 8K0S130296 8K0S130300 8K0S130304 8K0S130324 8K0S130345 8K0S130347 8K0S130546 8K0S130548 8K0S130552 8K0S130556 8K0S130559 8K0S130565 8K0S130567 8K0S130571 8K0S130574 8K0S130726 8K0S130751 8K0S130768 8K0S130771- 130773 8K0S130819 8K0S130951 8K0S131043 8K0S131046 8K0S131120 8K0S131133 8K0S131328 8K0S131330 8K0S131449- 132162 9K0S132163- 135000 9K0S135001- 149208 9KOS137160 OKOS149422
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 20, 2015.
- FDA classified it on Apr 29, 2015.
- FDA’s Enforcement Report published it on May 6, 2015.
- FDA terminated it on May 18, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.