Nikkiso DBB-06 Hemodialysis Delivery System Recall: Device Lacks Premarket Approval
Nikkiso recalls DBB-06 Hemodialysis Delivery Systems with serial numbers listed. Device lacks premarket approval, posing potential safety risks. Consumers should stop using affected units immediately.
Stop using this now
Device lacks premarket approval.
Contact the company
What happened, in plain English
Nikkiso is recalling DBB-06 Hemodialysis Delivery Systems that lack premarket approval. This means the device hasn't been approved by the FDA for safety before being sold, which could lead to health risks for users. Read more at govinfonow.com/recall/61499-nikkiso-dbb-06-hemodialysis-delivery-system-recall-device-lacks-premarket.
Source Summary by GovInfoNow · govinfonow.com/recall/61499-nikkiso-dbb-06-hemodialysis-delivery-system-recall-device-lacks-premarket · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0456-2022
Cite this page
“Nikkiso DBB-06 Hemodialysis Delivery System Recall: Device Lacks Premarket Approval.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61499-nikkiso-dbb-06-hemodialysis-delivery-system-recall-device-lacks-premarket. Based on FDA recall #Z-0456-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0456-2022%22&limit=1).
Why it’s dangerous
The device lacks premarket approval, meaning it hasn't been tested or approved by the FDA for safety before being sold. This could lead to health risks such as complications during dialysis treatments if the device malfunctions.
Who’s affected
People using the DBB-06 Hemodialysis Delivery System with the listed serial numbers are affected. Patients undergoing dialysis are most at risk due to the device's critical medical purpose.
How to tell if you have this one
Check if your DBB-06 Hemodialysis Delivery System has a serial number from the list provided in the recall notice. The device was sold by Nikkiso Ltd - Shizuoka Plant.
- Brand
Nikkiso- Category
Medical device
What to do — step by step
Stop Using It Now
Immediately stop using the DBB-06 Hemodialysis Delivery System if it has a serial number listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “Distributed nationwide to NY, MO, WA, CA, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Missouri, New York, Tennessee, Washington.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0456-2022 (November 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0456-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.