FDA Medical devices recall ·
MedicaLyte Bicarbonate Powder recall
- Recall number
- Z-3134-2026
- Date
- (initiated August 5, 2026)
- Company / brand
- Nipro Renal Soultions USA, Corporation
509 Fishing Creek Rd, Lewisberry, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,327 cases
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Why was it recalled?
Hemodialysis concentrates contain high endotoxin levels
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
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.
States: Florida Georgia Illinois Maryland Michigan North Carolina New Jersey Nevada Ohio Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3134-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.