Bicarby Dialysate Recall Due to Luer-Lock Leak Risk
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Fresenius Medical Care Holdings, Inc. is recalling over 1.7 million units of Bicarby Dialysate due to reported leaks that may create a slip and fall hazard.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Fresenius Medical Care Holdings, Inc. initiated a voluntary recall after an increased number of leaks were reported by users. The issue involves potential Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use, presenting a slip and fall hazard from fluid on the floor.
Which Products Are Affected
The recall covers Bicarby Dialysate with model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G. Affected UDI-DIs are 00840861102839, 00840861102853, 00840861102822, 00840861102914, 00840861102846, and 00840861102945. All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026, are included. A total of 1,756,108 units are affected under recall number Z-2321-2026. Distribution is limited to the states of NY, TN, and TX.
What You Should Do
Users should be aware of the potential for leaks during product preparation. The recalling firm notified users via letter.
Why This Matters
This Class II recall addresses a defect that could lead to fluid leaks and associated slip and fall risks during dialysis treatment preparation.
Source
FDA recall Z-2321-2026; Fresenius Medical Care Holdings, Inc., Waltham, MA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,243 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.