GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B — Class II medical device recall Z-3091-2026
Ongoing recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2026-09-09, distributed nationwide. Complaints of blue-green discoloration in product
| Recall number | Z-3091-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2026-07-14 |
| Classified | 2026-09-03 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| UPC / GTIN / UDI-DI | 00840861101535, 00840861101597 |
| Lot numbers | 26AXGF014, 26AXGF015, 26AXGF016, 26AXGF017, 26AXGF018, 26BXGF008, 26BXGF009 |
Product
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Reason for recall
Complaints of blue-green discoloration in product
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-3091-2026. 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.