FDAClass II · Medical device · Recall Z-3093-2026 · Recalled September 9, 2026

Citrasate recall — Fresenius Medical Care Renal Therapies Group, LLC

Agency report date: September 9, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Citrasate
Company / brand: Fresenius Medical Care Renal Therapies Group
Lot / serial / date codes: 1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041.
Distribution: Worldwide distribution - US Nationwide and the country of Mexico.

Agency product description and boundaries

Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Complaints of blue-green discoloration in product

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Citrasate recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3093-2026
Brand: All Fresenius Medical Care Renal Therapies Group recalls
Classification: Class II
Units affected: 56,036 cs; 1,788 drums; 204 ea
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Citrasate recall status

Companies & origin

Recalling firm location: Waltham, MA, United States
Firm address: 920 Winter St Bld 920, N/A, 02451-1521

Identifying details (verbatim from the notice)

Product codes / lots: 1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041.
Distribution: Worldwide distribution - US Nationwide and the country of Mexico.
Firm notified the public via: Letter
FDA event ID: 99543
Recall initiated: July 14, 2026
FDA classified: September 3, 2026
FDA report date: September 9, 2026

Other medical device recalls from around the same time

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BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall — BMC Medical Co., Ltd.FDA · August 26, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall — Boston Scientific CorporationFDA · August 26, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System recall — Boston Scientific CorporationFDA · August 26, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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