Class II — Nikkiso Ltd - Shizuoka Plant
| Recalling firm | NIKKISO CO., LTD. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Device lacks premarket approval. |
| Product | DBB-06 Hemodialysis Delivery System |
| Quantity | 781 units |
| Distribution | Distributed nationwide to NY, MO, WA, CA, and TN. |
| Initiated | 2021-11-24 |
| Classified | 2022-01-05 |
| Recall number | Z-0456-2022 |
| 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 — Nikkiso Ltd - Shizuoka Plant (Z-0456-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88641/
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