FDA recall, , Moderate risk
Fresenius Medical Care Bicarby Dialysate
Bicarby Dialysate can leak during preparation, posing a slip and fall hazard.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Medical Care Holdings, Inc., of Waltham, Massachusetts, is notifying users of the potential for Bicarby Dialysate luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment, given the increased number of leaks reported by users. This issue presents the potential of a slip and fall hazard associated with fluid on the floor. The company began the recall on May 12, 2026, and the FDA added it to its Enforcement Report on June 5, 2026.
The recalled Bicarby Dialysate was distributed nationwide in the states of New York, Tennessee, and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Bicarby Dialysate
- Model number
- RFP-400-G
- RFP-401-G
- RFP-402-G
- RFP-404-G
- RFP-407-G
- RFP-456-G
- UDI-DI
- 00840861102839
- 00840861102853
- 00840861102822
- 00840861102914
- 00840861102846
- 00840861102945
- Lot code
- All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026
Recall details
- Company began the recall
- Company
- Fresenius Medical Care Holdings, Inc.Waltham, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98877
- Recall number
- Z-2321-2026
- Quantity recalled
- 1,756,108 units
All recalls from Fresenius Medical Care Holdings, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
