Lower riskMedical device recall · FDA · Published May 7, 2026
Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk
Fresenius Medical Care recalls Bicarby Dialysate model RFP-400-G due to incorrect GTIN labeling that may lead to wrong potassium solution use. Affected units have specific lot codes.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
“Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49200-fresenius-medical-care-bicarby-dialysate-recall-incorrect-labeling-risk. Based on FDA recall #Z-2401-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2401-2026%22&limit=1).
The FDA announced on May 7, 2026, that Fresenius Medical Care Holdings Inc. is recalling Bicarby Dialysate due to an error in the GTIN labeling. The agency stated that unrecognized use of a potassium solution with a concentration differing from the prescription may result if the incorrect label is used as the sole identification source.
How to tell if you have it
Brand: Fresenius Medical Care
Product: Bicarby Dialysate
Model number: RFP-400-G
UDI-DI: 00840861102839
Lot codes: 25SG06026, 25SG06027
Distribution: Domestic TX
The hazard
The recall involves an error in the GTIN labeling on Bicarby Dialysate bags. The FDA noted that while case labeling, lot numbers, and printed product labels correctly identify the code and solution, using the incorrect GTIN as the singular source for identification could lead to unrecognized use of a potassium solution with a concentration differing from the prescription.
Context
GovInfoNow's records show Fresenius Medical Care Holdings Inc. has had 44 other recalls on record since April 14, 2014. Recent brand recalls include a May 12, 2026 notice for Bicarby Dialysate leaks and a May 11, 2026 recall of the 5008X Blood Tubing Set due to online port errors. Other recent recalls of similar products include Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), Fresenius Medical Care 5008X Blood Tubing Set Recall (Aug. 10, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (Aug. 10, 2026).
How to tell if you have this one
Check for model number RFP-400-G on the product. Affected units have lot codes 25SG06026 or 25SG06027. The product may have UDI-DI code 00840861102839.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labeling
Verify the model number and lot codes on the product to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “Domestic: TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA published this recall 41 days 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-2401-2026 (May 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2401-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.