Class IIOngoingZ-3136-2026
Nipro Renal Soultions USA, Corporation recalls Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D
Hemodialysis concentrates contain high endotoxin levels
Nipro Renal Soultions…PASep 16, 2026
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Class IIOngoingZ-3135-2026
Nipro Renal Soultions USA, Corporation recalls Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Hemodialysis concentrates contain high endotoxin levels
Nipro Renal Soultions…PASep 16, 2026
Class IIOngoingZ-3134-2026
Nipro Renal Soultions USA, Corporation recalls MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X
Hemodialysis concentrates contain high endotoxin levels
Nipro Renal Soultions…PASep 16, 2026
Class IIOngoingZ-3133-2026
Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Hemodialysis concentrates contain high endotoxin levels
Nipro Renal Soultions…PASep 16, 2026
Class IIOngoingZ-3093-2026
Fresenius Medical Care Renal Therapies Group, LLC recalls Citrasate
Complaints of blue-green discoloration in product
Fresenius Medical Care…MASep 9, 2026
Class IIOngoingZ-3092-2026
Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte
Complaints of blue-green discoloration in product
Fresenius Medical Care…MASep 9, 2026
Class IIOngoingZ-3091-2026
Fresenius Medical Care Renal Therapies Group, LLC recalls GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B
Complaints of blue-green discoloration in product
Fresenius Medical Care…MASep 9, 2026
Class IIOngoingZ-2401-2026
Fresenius Medical Care Holdings, Inc. recalls Bicarby Dialysate
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…
Fresenius Medical Care…MAJun 17, 2026
Class IIOngoingZ-2321-2026
Fresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate
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 f…
Fresenius Medical Care…MAJun 17, 2026