Class II — Nipro Medical Corporation
| Recalling firm | NIPRO CORPORATION |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Screw may loosen or fallout of Hemodialysis system |
| Product | Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only |
| Quantity | N/A |
| Distribution | US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC. |
| Initiated | 2025-10-27 |
| Classified | 2025-12-11 |
| Recall number | Z-0912-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nipro Medical Corporation (Z-0912-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97914/
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