MedicaLyte Bicarbonate Powder REF: DB+201-2 — Class II medical device recall Z-3134-2026
Ongoing recall by Nipro Renal Soultions USA, Corporation, reported 2026-09-16, distributed nationwide. Hemodialysis concentrates contain high endotoxin levels
| Recall number | Z-3134-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Renal Soultions USA, Corporation, Lewisberry, PA, United States |
| Recall initiated | 2026-08-05 |
| Classified | 2026-09-10 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | GT, PA |
| Quantity | 2,327 cases |
| Reason classes | sterility |
| Lot numbers | NDB5E004, NDB5M011 |
| Expiration dates | 2026-09-25, 2027-04-30, 2027-12-05 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3134-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.