NaturaLyte — Class II medical device recall Z-3092-2026
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-3092-2026 |
|---|---|
| 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 | 00840861101658, 00840861101696, 00840861101702, 00840861101740, 00840861101757, 00840861101849, 00840861101863, 00840861101887 |
| Lot numbers | 26AXAC041, 26AXAC050, 26AXAC051, 26AXAC052, 26AXAC056, 26AXAC058, 26AXAC059, 26AXAC062, 26AXAC064, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC011, 26BXAC012, 26BXAC013, 26BXAC034, 26BXAC037, 26BXAC042, 26BXAC043, 26BXAC045, 26BXAC048, 26BXAC049, 26BXAC051 |
Product
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid 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-3092-2026. 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.