Nipro recalls
3 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for Nipro and put it in plain English.
Recent recalls
Nipro MedicaLyte and Citric Complete dialysis concentrates recalled for endotoxinNipro is recalling four hemodialysis concentrate products because they may contain high levels of endotoxin, a substance from bacteria. The recall covers about 13,000 cases and 100 drums across the US, Guatemala, and Panama, with US distribution in FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA. No injuries have been reported.
SeriousFDASep 16, 20264 products
- Stop using NIPRO Conductivity Standard Solution
NIPRO Technical Services' Conductivity Standard Solutions (models 10001, 10011, 10021, 10032, 10040, 10040c, 10041) have a defect that causes incorrect conductivity readings. These solutions are used to calibrate meters that measure dialysate (the fluid used in dialysis treatment). If calibration is inaccurate, dialysis machines may report wrong conductivity values, which could affect treatment safety.
ModerateFDAFeb 4, 2026
- Check your Nipro Surdial DX hemodialysis system
A screw in certain Nipro Surdial DX hemodialysis systems may loosen or fall out during use. This is a medical device used in dialysis treatment. The affected units have specific serial numbers issued between 2020 and 2024.
ModerateFDADec 17, 2025