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# Nipro Renal Recalls MedicaLyte Hemodialysis Product
- URL: https://www.fdaweb.com/nipro-renal-recalls-medicalyte-hemodialysis-product/
- Published: 2025-05-15T12:00:00.000Z
- Updated: 2026-09-14T15:11:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159189

Nipro Renal Soultions has recalled (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate, a dialysate concentrate for hemodialysis, due to the potential for the presence of visible foreign matter in the plastic bottles. Nipro Renal notified consignees on 4/11 through a “Urgent: Medical Device Recall” letter that instructed them to identify and isolate any inventory from the affected lots, a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213351&ref=fdaweb.com) says. FDA has identified the cause of the recall to be process control-related.