Fresenius Medical Care — Class II medical device recall Z-3017-2026
Ongoing recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2026-09-02, distributed nationwide. Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-,
| Recall number | Z-3017-2026 |
|---|---|
| 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 | 2026-06-30 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,140 systems |
| UPC / GTIN / UDI-DI | 00840861102099, 00840861102112 |
| Serial numbers | 191130, 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5T0S291145, 5T0S291146, 5T0S291148, 5T0S291149, 5T0S291150, 5T0S291151, 5T0S291152, 5T0S291154, 5T0S291155, 5T0S291156, 5T0S291157, 5T0S291158, 5T0S291159 and 475 more |
| Model numbers | 191126, 191130 |
Product
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Reason for recall
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
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-3017-2026. 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.