Nikkiso Ltd - Shizuoka Plant: DBB-06 Hemodialysis Delivery System

Recall number

Z-0456-2022

Recalling firm

Nikkiso Ltd - Shizuoka Plant

Product

DBB-06 Hemodialysis Delivery System

Status

Open, Classified

Initiated

2021-11-24

Posted

not on file

Terminated

not on file

Reason

Device lacks premarket approval.

Root cause

Under Investigation by firm

Action

Nikkiso notified customers on about 11/24/2021, via letter titled MEDICAL DEVICE RECALL. Customers were instructed that the affected functions have been disabled on affected units and no actions need to be taken. Customers were asked to complete the provided response form and return it to the technical service when they visit each facility to complete the software update. Questions can be directed to the firm at at 901-310-1567 option 1, Monday Friday, 9:00am-5:00pm CST, or by email at CS@nikkisomedical.us

Quantity

781 units

Distribution

Distributed nationwide to NY, MO, WA, CA, and TN.

Lot, serial or model codes

Model Number: DBB-06; Serial Numbers: 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, J1911354, J1911217, J1907939, J1911035, J1908584, J1911039, J1906050, J1910494, J1909850, J1910560, J1908020, J1908115, J1907932, J1908118, J1910774, J1905789, J1905576, J1909116, J1910489, J1909312, J1908435, J1905791, J1905921, J1910116, J1910027, J1909407, J1909406, J1910491, J1909405, J1909952, J1910495, J1910023, J1909947, J1909945, J1909690, J1910296, J1910300, J1910112, J1910030, J1909414, J1909308, J1909942, J1909313, J1910118, J1905793, J1910690, J1905920, J1910686, J1910400, J1911038, J1910297, J1910115, J1910406, J1905927, J1910136, J1908417, J1908778, J1908034, J1907320, J1909122, J1908114, J1907116, J1908664, J1906921, J1908112, J1908870, J1908757, J1908120, J1908570, J1908291, J1907937, J1908441, J1908583, J1908658, J1908024, J1909022, J1908030, J1908770, J1909204, J1908285, J1907931, J1910862, J1908866, J1908426, J1908774, J1908033, J1908113, J1908750, J1906826, J1907119, J1909021, J1907122, J1908773, J1908659, J1908771, J1909200, J1909199, J1908779, J1909011, J1908571, J1909117, J1906927, J1910860, J1911223, J1911352, J1905787, J1905926, J1910969, J1909708, J1905799, J1911220, J1910562, J1910864, J1908025, J1907926, J1909109, J1909119, J1908751, J1908412, J1907106, J1909024, J1907033, J1908662, J1911115, J1914588, J1911222, J1905800, J1910857, J1910488, J1905795, J1905919, J1908752, J1910402, J1914584, J1905667, J1910869, J1908424, J1905918, J1905575, J1905798, J1908760, J1905579, J1910685, J1910691, J1911114, J1905923, J1908572, J1905922, J1905578, J1905581, J1905928, J1911027, J1911216, J1905584, J1911221, J1905666, J1911218, J1910868, J1905660, J1905582, J1905674, J1910687, J1908022, J1909208, J1909120, J1908107, J1910856, J1910779, J1910564, J1910863, J1905577, J1905930, J1909110, J1905801, J1908109, J1908768, J1911219, J1910694, J1906055, J1908772, J1914587, J1906053, J1911357, J1909304, J1908871, J1908663, J1908289, J1907126, J1908661, J1908294, J1908575, J1908769, J1905668, J1909305, J1909196, J1908578, J1909197, J1909195, J1908754, J1908117, J1909015, J1908026, J1909013, J1907105, J1906825, J1909112, J1908758, J1909206, J1910563, J1910775, J1909121, J1909203, J1907453, J1909111, J1907328, J1908867, J1908414, J1908775, J1911350, J1908761, J1909114, J1907928, J1907933, J1908416, J1908428, J1908437, J1908865, J1909019, J1909123, J1906926, J1907936, J1908749, J1908763, J1909115, J1909118, J1908110, J1908421, J1908580, J1908874, J1909207, J1908579, J1909302, J1908415, J1908873, J1907109, J1907318, J1907454, J1907927, J1907929, J1908021, J1908119, J1908280, J1908282, J1908423, J1908429, J1908442, J1908577, J1908651, J1908753, J1908759, J1909010, J1907128, J1907935, J1908031, J1908780, J1909014, J1906827, J1906830, J1907930, J1906829, J1906924, J1906925, J1906930, J1907029, J1907035, J1907037, J1907315, J1907324, J1907925, J1907938, J1908027, J1908028, J1908029, J1908032, J1908290, J1908419, J1908420, J1908430, J1908433, J1908436, J1908438, J1908440, J1908574, J1908576, J1908655, J1908781, J1908868, J1909016, J1909018, J1909023, J1909113, J1909198, J1906831, J1906834, J1907038, J1907117, J1907118, J1907124, J1908283, J1908284, J1908286, J1908413, J1908425, J1908432, J1908434, J1908652, J1908869, J1907125, J1908293, J1908418, J1908431, J1908573, J1908654, J1907326, J1908422, J1908653, J1907120, J1907325, J1908292, J1906838, J1906118, J1906400, J1906784, J1906824, J1906828, J1906835, J1906836, J1906928, J1906108, J1906121, J1906291, J1906404, J1906779, J1906780, J1906781, J1906782, J1906110, J1906113, J1906832, J1906931, J1906932, J1906933, J1906411, J1906109, J1906117, J1906282, J1906287, J1906405, J1906407, J1906409, J1906281, J1906286, J1906289, J1906292, J1906293, J1906294, J1906408, J1906116, J1906280, J1906283, J1906403, J1906783, J1907114, J1906929, J1907031, J1907032, J1907036, J1907115, J1907455, J1906833, J1906920, J1906934, J1907108, J1907322, J1907323, J1906107, J1906837, J1906922, J1907030, J1907121, J1907319, J1906778, J1906511, J1906663, J1906664, J1906667, J1906668, J1906669, J1906671, J1906672, J1906673, J1906675, J1906677, J1907458, J1907459, J1907460, J1907463, J1907464, J1907465, J1907466, J1907624, J1907625, J1907628, J1907630, J1907631, J1907633, J1907636, J1907637, J1907711, J1907712, J1907713, J1907714, J1907715, J1907716, J1907717, J1907719, J1907720, J1907722, J1907723, J1906410, J1906509, J1906510, J1906666, J1906670, J1906674, J1906770, J1907456, J1907457, J1907461, J1907627, J1907629, J1907632, J1907634, J1907635, J1907718, J1907725, J1906120, J1906676, J1906774, J1907462, J1907467, J1907626, J1907638, J1907721, J1907724, J1906773, J1906401, J1906499, J1906506, J1906507, J1906111, J1906115, J1906285, J1906402, J1906406, J1906498, J1906500, J1906501, J1906503, J1906290, J1906413, J1906497, J1906502, J1906505, J1906114, J1906119, J1906504, J1906772, J1906775, J1906776, J1906412, J1906665, J1906771, J1906777, J1906112, J1612940, J1707101, J1707103, J1707109, J1707138, J1704039, J1707116, J1707127, J1707129, J1707139, J1707145, J1707130, J1707137, J1707120, J1707111, J1707118, J1707119, J1707124, J1707125, J1707126, J1707134, J1707104, J1613227, J1707105, J1707106, J1707131, J1707140, J1707141, J1707117, J1707136, J1707144, J1707110, J1707121, J1707123, J1707128, J1707132, J1707135, J1702725, J1707115, J1707122, J1707143, J1708043, J1702641, J1707102, J1707142, J1702650, J1707107, J1707113, J1708033, J1708063, J1708069, J1707114, J1708044, J1708047, J1708049, J1708058, J1708066, J1707112, J1708035, J1708042, J1708060, J1707133, J1708056, J1608042, J1613054, J1612948, J1708046, J1708051, J1708059, J1708064, J1708067, J1708031, J1708054, J1708036, J1708038, J1708048, J1708055, J1708062, J1708032, J1708045, J1708065, J1703829, J1703837, J1704035, J1704046, J1704051, J1704052, J1708037, J1708041, J1708052, J1708061, J1708057, J1703831, J1703841, J1708053, J1703827, J1703840, J1708034, J1708039, J1708040, J1708068, J1702722, J1703828, J1703830, J1703833, J1703834, J1703836, J1703838, J1703839, J1703842, J1703843, J1703845, J1703846, J1704036, J1704037, J1704038, J1704041, J1704044, J1704045, J1704047, J1704048, J1704049, J1704050, J1704053, J1704054, J1704055, J1704056, J1612943, J1613043, J1613241, J1704043, J1702716, J1702727, J1612942, J1702637, J1702649, J1702711, J1613046, J1702715, J1702731, J1703844, J1702714, J1613044, J1702631, J1613036, J1702712, J1702718, J1613035, J1702632, J1702642, J1612947, J1702635, J1702726, J1613236, J1702634, J1702713, J1702717, J1702724, J1702728, J1702633, J1702639, J1702647, J1702723, J1702729, J1702730, J1703832, J1704042, J1702648, J1704040, J1612931, J1612932, J1612937, J1612939, J1612941, J1613042, J1613045, J1613048, J1612946, J1612930, J1612936, J1612944, J1613053, J1613051, J1613039, J1613040, J1613049, J1612934, J1613038, J1612938, J1613041, J1609143, J1609144, J1609145, J1609146, J1609147, J1609148, J1609149, J1609137, J1609138, J1609139, J1609140, J1609141, J1609142, J1612935, J1613037, J1613047, J1612945, J1613050, J1613052, J1609033, J1609034, J1609134, J1609135, J1609136, J1608930, J1608940, J1608947, J1609031, J1609032, J1609036, J1609132, J1609133, J1609027, J1609028, J1609029, J1609035, J1608943, J1608946, J1608941, J1608942, J1608944, J1608945, J1608938, J1608939, J1608040, J1608041

510(k) numbers

["K091978","K152938"]

PMA numbers

not on file

Product code

KDI

Firm FEI

3002807721

Firm city

Makinohara

Firm state

Shizuoka-Ken

Firm country

Japan

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy