DBB-06 Hemodialysis Delivery System — Class II medical device recall Z-0456-2022
Ongoing recall by Nikkiso Ltd - Shizuoka Plant, reported 2022-01-12, distributed nationwide. Device lacks premarket approval.
| Recall number | Z-0456-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nikkiso Ltd - Shizuoka Plant, Makinohara, N/A, Japan |
| Recall initiated | 2021-11-24 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Distributed | Nationwide (US) |
| Quantity | 781 units |
| Serial numbers | J1608040, J1608041, J1608042, J1608930, J1608938, J1608939, J1608940, J1608941, J1608942, J1608943, J1608944, J1608945, J1608946, J1608947, J1609027, J1609028, J1609029, J1609031, J1609032, J1609033, J1609034, J1609035, J1609036, J1609132, J1609133 and 475 more |
| Model numbers | DBB-06 |
Product
DBB-06 Hemodialysis Delivery System
Reason for recall
Device lacks premarket approval.
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-0456-2022. 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.