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BicarbyRecalls & reported problems across all models

Fresenius Medical Care Renal Therapies Group, LLC · 6 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Bicarby model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
2

We found 6 models of Bicarby by Fresenius Medical Care Renal Therapies Group, LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bicarby recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. May 12, 2026Class IIOpen, Classified

    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.

    Z-2321-2026 · Root cause: Process design · names 6 of these models · Recall details · FDA record ↗

  2. May 7, 2026Class IIOpen, Classified

    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.

    Z-2401-2026 · Root cause: Process control · Recall details · FDA record ↗

Bicarby models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Fresenius Medical Care Renal Therapies Group, LLC products

All Fresenius Medical Care Renal Therapies Group, LLC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page