FDA recall, , Moderate risk
Fresenius Medical Care Acid Concentrates
GRANUFLO Dry Acid Concentrate, NaturaLyte, and Citrasate have complaints of blue-green discoloration.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care Renal Therapies Group, LLC, of Waltham, Massachusetts, began a recall on July 14, 2026, for NaturaLyte Liquid Acid Concentrate for Bicarbonate Hemodialysis, GRANUFLO Dry Acid Concentrate, and Citrasate Liquid Acid Concentrate for Bicarbonate Hemodialysis due to complaints of blue-green discoloration in product. The recall was added to the FDA's Enforcement Report and classified on September 3, 2026, with distribution nationwide in the US and in Mexico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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- UDI-DI
- 00840861101658
- 00840861101696
- 00840861101702
- 00840861101740
- 00840861101757
- 00840861101849
- 00840861101863
- 00840861101887
- Lot code
- 26AXAC056
- 26AXAC050
- 26BXAC012
- 26BXAC042
- 26BXAC013
- 26BXAC045
- 26AXAC051
- 26BXAC011
- 26BXAC043
- 26AXAC052
- 26AXAC062
- 26AXAC064
- 26AXAC041
- 26AXAC058
- 26AXAC059
- 26AXAC065
- 26BXAC001
- 26BXAC003
- 26BXAC005
- 26BXAC034
- 26BXAC049
- 26BXAC051
- 26BXAC037
- 26BXAC048
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- UDI-DI
- 00840861101535
- 00840861101597
- Lot code
- 26AXGF015
- 26AXGF016
- 26AXGF017
- 26BXGF008
- 26BXGF009
- 26AXGF014
- 26AXGF018
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- UDI-DI
- 00840861101344
- 00840861101351
- 00840861101375
- Lot code
- 26BXAC038
- 26BXAC039
- 26BXAC040
- 26BXAC041
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Mexico.
- Company
- Fresenius Medical Care Renal Therapies Group, LLCWaltham, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99543
- Recall numbers
- Z-3091-2026 to Z-3093-2026
All recalls from Fresenius Medical Care Renal Therapies Group, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
