MedicaLyte Liquid Bicarbonate Concentrate — Class I medical device recall Z-1730-2025
Ongoing recall by Nipro Renal Soultions USA, Corporation, reported 2025-05-21, distributed nationwide. Potential for the presence of visible foreign matter.
| Recall number | Z-1730-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Renal Soultions USA, Corporation, Lewisberry, PA, United States |
| Recall initiated | 2025-04-11 |
| Classified | 2025-05-14 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | GT, PA |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 00817411022817, 00817411022824, 10817411022814, 10817411022821 |
| Lot numbers | N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044 |
| Model numbers | 36.83X |
Product
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).
Reason for recall
Potential for the presence of visible foreign matter.
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-1730-2025. 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.