FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Medical device · Recalled June 17, 2026

Bicarby Dialysate recall — Fresenius Medical Care Holdings, Inc.

Hazard: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2401-2026
Brand
Fresenius Medical Care Holdings
Classification
Class II
Units affected
4,752
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Bicarby Dialysate; Model number: RFP-400-G;

Affected products

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
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
Distribution
Domestic: TX.
Firm notified the public via
Letter
FDA event ID
98892
Recall initiated
May 7, 2026
FDA classified
June 11, 2026
FDA report date
June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 2:00 AM UTC.

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