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# Nipro Class 1 Recall of Hemodialysis Chemical
- URL: https://www.fdaweb.com/nipro-class-1-recall-of-hemodialysis-chemical/
- Published: 2025-06-13T12:00:00.000Z
- Updated: 2026-09-14T15:14:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159354

Nipro has recalled (Class 1) its MedicaLyte liquid bicarbonate concentrate after receiving reports about “visual irregularities in some product jugs,” according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/liquid-bicarbonate-concentrate-recall-nipro-removes-medicalyte-liquid-bicarbonate-concentrate-due?utm%5Fmedium=email&utm%5Fsource=govdelivery). “Returned units were sent to a third-party laboratory for analysis, where bacterial and fungal particles were identified,” it says, adding that risks associated with the use of contaminated dialysate include infections, treatment disruptions, sepsis, and possible death.

Dialysate is part of a hemodialysis system that removes waste, toxins, and excess fluids from the body in patients with kidney failure, the company says. “If the contaminated product is used, the hemodialysis machine will need to be disinfected following the dialysis machine manufacturer’s recommendations,” it adds. To date, Nipro has received reports of one serious injury and one death.