CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled

Fresenius Medical Care Renal Therapies Group is recalling Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.

Quantity recalled27,216 cs; 2,316 ea

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3091-2026
FDA event ID: 99543
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jul 2026
FDA classified: 3 Sep 2026
Reported: 9 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jul 2026	Recall initiated by company
3 Sep 2026	Classified by FDA	+51 days
9 Sep 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints of blue-green discoloration in product

Product as listed by the FDA

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

Where it was distributed

Worldwide distribution - US Nationwide and the country of Mexico.

Nationwide

Questions about this recall

Why was it recalled?

Complaints of blue-green discoloration in product

Which lots are affected?

1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.

Where was it sold?

Worldwide distribution - US Nationwide and the country of Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99543

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

More recalls from Fresenius Medical Care Renal Therapies Group

All 35

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	CombiSet Hemodialysis Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

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