FDA recall Z-3134-2026

Nipro Renal Soultions USA, Corporation · Class II · device

Product

MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

Key facts

Status
Ongoing
Initiation date
2026-08-05
Report date
2026-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lewisberry, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3134-2026