MEDICAL DEVICE RECALLMODERATE

GRANUFLO Dry Acid Concentrate

Fresenius recalls GRANUFLO Dry Acid Concentrate (0FD2251-3B, 0FD3251-3B) over blue-green discoloration.

What to do

Stop using the recalled GRANUFLO Dry Acid Concentrate and contact Fresenius Medical Care for instructions on returning the product and obtaining a replacement or refund.

Recalled

2026-07-14

Listed

2026-09-03

Updated

2026-09-04

Agency

FDA

Firm

Fresenius Medical Care Renal Therapies Group, LLC

Recall ID

99543

Status

ONGOING

Why it was recalled

Fresenius Medical Care is recalling GRANUFLO Dry Acid Concentrate for Bicarbonate Hemodialysis, product numbers 0FD2251-3B and 0FD3251-3B, due to complaints of blue-green discoloration in the product.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Product	Lot code	UDI-DI
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis	26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009, 26AXGF014, 26AXGF018	00840861101535, 00840861101597
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis	26BXAC038, 26BXAC039, 26BXAC040, 26BXAC041	00840861101344, 00840861101351, 00840861101375
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis	26AXAC056, 26AXAC050, 26BXAC012, 26BXAC042, 26BXAC013, 26BXAC045, 26AXAC051, 26BXAC011, 26BXAC043, 26AXAC052, 26AXAC062, 26AXAC064, 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051, 26BXAC037, 26BXAC048	00840861101658, 00840861101696, 00840861101702, 00840861101740, 00840861101757, 00840861101849, 00840861101863, 00840861101887

Timeline

2026-07-14Firm initiated recall
2026-09-03Publicly announced
2026-09-04Listed on Recall Canary
2026-09-04Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification