Reported Jan 12, 2022 · Ongoing

DBB-06 Hemodialysis Delivery System

Nikkiso Ltd. - Shizuoka Plant

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nikkiso Ltd - Shizuoka Plant · 498 1 · Makinohara, N/A · N/A

Is this the product you have?

  • DBB-06 Hemodialysis Delivery System
Lot codes and dates
  • Model NumberDBB-06
  • Serial Numbers

    781 of 781 codes

    • J1910861
    • J1905670
    • J1905916
    • J1910971
    • J1909943
    • J1909306
    • J1908111
    • J1909202
    • J1907127
    • J1908023
    • J1910962
    • J1910866
    • J1910028
    • J1909307
    • J1907329
    • J1909853
    • J1908776
    • J1908108
    • J1914585
    • J1908762
    • J1909020
    • J1908872
    • J1908439
    • J1908777
    • J1910867
    • J1911026
    • J1907034
    • J1911033
    • J1908665
    • J1909209
    • J1909705
    • J1906923
    • J1911029
    • J1910870
    • J1910967
    • J1911040
    • J1910499
    • J1905788
    • J1910558
    • J1909689
    • J1910498
    • J1909315
    • J1909662
    • J1906052
    • J1910692
    • J1909412
    • J1908116
    • J1910688
    • J1908582
    • J1908657
    • J1909017
    • J1908281
    • J1908581
    • J1909012
    • J1908660
    • J1907321
    • J1907123
    • J1907317
    • J1911036
    • J1905580
Amount recalled
781 units

Where it was sold

Why it was recalled

Device lacks premarket approval.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.