Use caution Medical device recall · FDA · Published May 12, 2026

Fresenius Bicarby Dialysate Leaks Risk: Slip and Fall Hazard

Fresenius Medical Care recalls Bicarby dialysate models RFP-400-G to RFP-456-G due to potential leaks causing slip and fall hazards. Affected units were produced from January 2025 to January 2026.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2321-2026Medical device Fresenius Medical Care ›

Use caution until it’s fixed

Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is recalling specific Bicarby dialysate models because leaks during setup could cause slippery floors and slip/fall injuries. This affects dialysis patients and healthcare workers using these products. Read more at govinfonow.com/recall/49182-fresenius-bicarby-dialysate-leaks-risk-slip-and-fall-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/49182-fresenius-bicarby-dialysate-leaks-risk-slip-and-fall-hazard · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2321-2026

Cite this page

“Fresenius Bicarby Dialysate Leaks Risk: Slip and Fall Hazard.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49182-fresenius-bicarby-dialysate-leaks-risk-slip-and-fall-hazard. Based on FDA recall #Z-2321-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2026%22&limit=1).

Fresenius Medical Care Holdings, Inc. recalled Bicarby Dialysate due to potential luer-lock leaks that present a slip and fall hazard, the FDA said on May 12, 2026. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Fresenius Medical Care
Product: Bicarby Dialysate
Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G
Lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026

The hazard

The recall addresses the potential for Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors (May 11, 2026), Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk (May 7, 2026), and Fresenius Recalls DELFLEX Dialysis Bags Due to Sterility Risk (April 6, 2026).

How to tell if you have this one

Check for model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, or RFP-456-G. These units were produced from January 13, 2025, through January 13, 2026.

Brand
Fresenius Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify if your dialysate has one of the model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, or RFP-456-G.
Stop Using if Leaking
If you notice leaks during preparation, stop using the dialysate immediately to prevent slips and falls.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution in the states of NY, TN and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: New York, Tennessee, Texas.

Recall timeline

FDA published this recall 36 days after the firm started it.

May 12, 2026Firm started the recall
Jun 5, 2026FDA classified it Class II
Jun 17, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Fresenius Medical Care recalls

Link to this recall

<a href="https://govinfonow.com/recall/49182-fresenius-bicarby-dialysate-leaks-risk-slip-and-fall-hazard">Fresenius Bicarby Dialysate Leaks Risk: Slip and Fall Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2321-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2321-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.