Hemodialysis System — Class II medical device recall Z-0912-2026
Ongoing recall by Nipro Medical Corporation, reported 2025-12-17, distributed nationwide. Screw may loosen or fallout of Hemodialysis system
| Recall number | Z-0912-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nipro Medical Corporation, Doral, FL, United States |
| Recall initiated | 2025-10-27 |
| Classified | 2025-12-11 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00383790008815 |
| Serial numbers | 20EW0001, 20EW0002, 20EW0005, 20EW0006, 20EW0007, 20EW0008, 20EW0009, 20EW0010, 20EW0011, 20EW0012, 20EW0013, 20EW0014, 20EW0015, 20EW0016, 20EW0017, 20EW0018, 20EW0019, 20EW0020, 20EW0021, 20EW0022, 20EW0023, 20EW0024, 20EW0025, 20EW0026, 20EW0027 and 475 more |
Product
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Reason for recall
Screw may loosen or fallout of Hemodialysis system
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-0912-2026. 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.