Moderate riskFDA DeviceSep 9, 2026Class II

Fresenius GRANUFLO Dry Acid Concentrate recalled for blue-green discoloration

Fresenius Medical Care has recalled certain lots of GRANUFLO Dry Acid Concentrate used in hemodialysis machines after receiving reports of blue-green discoloration in the product. The affected product numbers are 0FD2251-3B and 0FD3251-3B, with specific lot numbers listed by the FDA.

From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls

What to do

Check if you use GRANUFLO Dry Acid Concentrate and verify the product number and lot number against the FDA recall notice
Contact your dialysis provider or Fresenius Medical Care immediately if you have affected product
Do not use affected lots until you receive guidance from your healthcare provider or the manufacturer

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Sold in: Nationwide
Made for: All ages

This recall covers 3 products — see all of them.

Details

Units affected: 27,216 cs; 2,316 ea
Illnesses reported: None reported
Manufactured in: 920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification: Class II
Recall number: Z-3091-2026

In the FDA's words

Description: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis Complaints of blue-green discoloration in product 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018. Distribution: Worldwide distribution - US Nationwide and the country of Mexico. Affected quantity: 27,216 cs; 2,316 ea
Hazard: Complaints of blue-green discoloration in product

3 products in this recall

GRANUFLO, NaturaLyte and Citrasate recalled for blue-green discoloration

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

The agency lists each product separately. Check every one you might have.

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis (this page)
Z-3091-2026 · 27,216 cs; 2,316 ea
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, 13-225…
Z-3092-2026 · 2,998 cs; 68 ea
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbona…
Z-3093-2026 · 56,036 cs; 1,788 drums; 204 ea