Lewisberry, PA, United States
Nipro Renal Soultions USA, Corporation recalls
3 recalls recorded since 2018, most recently on 5 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 5 August 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3133-2026, Z-3136-2026, Z-3134-2026, Z-3135-2026
- MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Ongoing Class I Medical devices
- Recall started
- 11 April 2025
- Reason
- Potential for the presence of visible foreign matter.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, IL, KS, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, PR. International distribution to Guatemala and Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1730-2025
- MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
Ongoing Class II Medical devices
- Recall started
- 22 November 2024
- Reason
- The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
- Distribution
- US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0820-2025
- Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.