CLASS II ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report

Plum Duo recalled by ICU Medical

ICU Medical is recalling Plum Duo, distributed nationwide in the US. The recall was initiated on 22 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 400020401: UDI/DI 400020401, Serial/Lot Numbers: 50000184; UDI/DI +M335400021, Serial/Lot Numbers: 50002748, 50002774, 50001647, 50001654, 50001601, 50001615, 50001651, 50002547, 50002577, 50002678, 50002689, 50002750, 50002751, 50002755, 50002773, 50002788, 50002798, 50002799, 50002801, 50002807, 50002808, 50002818, 50002819, 50002820, 50002821, 50002822, 50002823, 50002824, 50002825, 50002828, 50002832, 50002835, 50002837, 50002839, 50002840, 50002844, 50002845, 50002847, 50002851, 50002853, 50002858, 50002892, 50003000, 50003002, 50003009, 50003023, 50003026, 50003029, 50003033, 50003034, 50003035, 50003036, 50003039, 50003043, 50003045, 50003051, 50003054, 50003058, 50003059, 50003060, 50003062, 50003063, 50003065, 50003087, 50003092, 50003126, 50003143, 50003157, 50003167, 50003201, 50003232, 50003241, 50003244, 50003246, 50003257, 50003259, 50003260, 50003261, 50003262, 50003266, 50003267, 50003268, 50003269, 50003272, 50003274, 50003277, 50003278, 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50002998, 50003003, 50003005, 50003008, 50003010, 50003013, 50003014, 50003073, 50003200; 2) 400021001: UDI/DI 400021001, Serial/Lot Numbers: 50000070; UDI/DI +M335400021, Serial/Lot Numbers: 50000004, 50000005, 50000006, 50000007, 50000008, 50000009, 50000010, 50000011, 50000012, 50000013, 50000014, 50000015, 50000016, 50000017, 50000018, 50000019, 50000020, 50000021, 50000022, 50000023, 50000024, 50000025, 50000026, 50000027, 50000028, 50000029, 50000030, 50000031, 50000032, 50000033, 50000034, 50000035, 50000036, 50000037, 50000038, 50000039, 50000040, 50000041, 50000042, 50000043, 50000044, 50000045, 50000046, 50000047, 50000048, 50000049, 50000050, 50000051, 50000052, 50000053, 50000054, 50000055, 50000056, 50000057, 50000058, 50000059, 50000060, 50000061, 50000062, 50000063, 50000064, 50000065, 50000066, 50000067, 50000068, 50000069, 50000071, 50000072, 50000073, 50000074, 50000075, 50000076, 50000077, 50000078, 50000079, 50000080, 50000081, 50000082, 50000083, 50000084, 50000086, 50000087, 50000088, 50000089, 50000090, 50000091, 50000092, 50000093, 50000094, 50000095, 50000096, 50000097, 50000098, 50000099, 50000100, 50000101, 50000102, 50000103, 50000104, 50000105, 50000106, 50000107, 50000108, 50000109, 50000110, 50000111, 50000112, 50000113, 50000114, 50000115, 50000116, 50000117; 3) 400021003: UDI/DI +M335400021, Serial/Lot Numbers: 80000052, 80000053, 80000054, 80000055, 80000056, 80000057, 80000058, 80000059, 80000060, 80000061, 80000062, 80000063, 80000064, 80000065, 80000066, 80000067, 80000068, 80000069, 80000071, 80000072, 80000073, 80000074, 80000075, 80000076, 80000078, 80000079, 80000080, 80000081, 80000082, 80000083, 80000084, 80000085, 80000086, 80000087, 80000089, 80000090, 80000091, 80000092, 80000093, 80000094, 80000095, 80000096, 80000097, 80000098, 80000099, 80000100, 80000101, 80000102, 80000103, 80000104, 80000024, 80000027, 80000028, 80000030, 80000031, 80000032, 80000034, 80000035, 80000037, 80000038, 80000039, 80000041, 80000042, 80000043, 80000044, 80000045, 80000046, 80000047, 80000048, 80000049, 80000051, 80000001, 80000002, 80000003, 80000006, 80000007, 80000008, 80000009, 80000010, 80000011, 80000012, 80000013, 80000014, 80000015, 80000017, 80000021, 80000022, 80000023, 80000025, 80000026.

Quantity recalled1701 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1990-2025
FDA event ID: 96777
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class II
Status: Ongoing
Recall initiated: 22 Apr 2025
FDA classified: 18 Jun 2025
Reported: 25 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

22 Apr 2025	Recall initiated by company
18 Jun 2025	Classified by FDA	+57 days
25 Jun 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

Where it was distributed

Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

Nationwide California Florida Iowa Kentucky Massachusetts Mississippi New York Pennsylvania Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

1) 400020401: UDI/DI 400020401, Serial/Lot Numbers: 50000184; UDI/DI +M335400021, Serial/Lot Numbers: 50002748, 50002774, 50001647, 50001654, 50001601, 50001615, 50001651, 50002547, 50002577, 50002678, 50002689, 50002750, 50002751, 50002755, 50002773, 50002788, 50002798, 50002799, 50002801, 50002807, 50002808, 50002818, 50002819, 50002820, 50002821, 50002822, 50002823, 50002824, 50002825, 50002828, 50002832, 50002835, 50002837, 50002839, 50002840, 50002844, 50002845, 50002847, 50002851, 50002853, 50002858, 50002892, 50003000, 50003002, 50003009, 50003023, 50003026, 50003029, 50003033, 50003034, 50003035, 50003036, 50003039, 50003043, 50003045, 50003051, 50003054, 50003058, 50003059, 50003060, 50003062, 50003063, 50003065, 50003087, 50003092, 50003126, 50003143, 50003157, 50003167, 50003201, 50003232, 50003241, 50003244, 50003246, 50003257, 50003259, 50003260, 50003261, 50003262, 50003266, 50003267, 50003268, 50003269, 50003272, 50003274, 50003277, 50003278, 50003279, 50003280, 50003281, 50003282, 50003285, 50003286, 50003287, 50003288, 50003290, 50003291, 50003292, 50003293, 50003298, 50003299, 50003300, 50003301, 50003302, 50003305, 50003307, 50003308, 50003309, 50003311, 50003312, 50003316, 50003317, 50003319, 50003329, 50003331, 50003334, 50003335, 50003339, 50003340, 50003343, 50003345, 50003352, 50003360, 50003403, 50003415, 50003431, 50003433, 50003456, 50003460, 50003485, 50003492, 50003497, 50003498, 50003500, 50003514, 50003524, 50003548, 50003575, 50003603, 50003604, 50003615, 50003617, 50003689, 50003690, 50003702, 50003716, 50003736, 50003754, 50003757, 50003779, 50003826, 50003830, 50003835, 50003862, 50003867, 50003873, 50003874, 50003883, 50003937, 50003950, 50003958, 50003975, 50003982, 50003983, 50003988, 50003990, 50003992, 50003995, 50004006, 50004023, 50004074, 50004077, 50004099, 50004106, 50004121, 50004125, 50004136, 50000124, 50000125, 50000126, 50000127, 50000128, 50000129, 50000130, 50000131, 50000132, 50000133, 50000134, 50000135, 50000136, 50000137, 50000138, 50000139, 50000140, 50000141, 50000142, 50000143, 50000144, 50000145, 50000146, 50000147, 50000148, 50000149, 50000150, 50000151, 50000152, 50000153, 50000154, 50000155, 50000156, 50000157, 50000158, 50000159, 50000160, 50000161, 50000162, 50000163, 50000164, 50000165, 50000166, 50000167, 50000168, 50000169, 50000170, 50000171, 50000172, 50000173, 50000174, 50000175, 50000176, 50000177, 50000178, 50000179, 50000180, 50000181, 50000182, 50000183, 50000185, 50000186, 50000187, 50000188, 50000189, 50000190, 50000191, 50000192, 50000193, 50000194, 50000195, 50000196, 50000197, 50000198, 50000199, 50000200, 50000201, 50000202, 50000203, 50000204, 50000205, 50000206, 50000207, 50000208, 50000209, 50000210, 50000211, 50000212, 50000213, 50000214, 50000215, 50000216, 50000217, 50000218, 50000219, 50000220, 50000222, 50000223, 50000224, 50000225, 50000226, 50000227, 50000228, 50000229, 50000230, 50000231, 50000232, 50000233, 50000234, 50000235, 50000236, 50000237, 50000240, 50000264, 50000268, 50000270, 50000271, 50002115, 50002176, 50002178, 50002184, 50002211, 50002224, 50002239, 50002251, 50002280, 50002281, 50002290, 50002292, 50002293, 50002294, 50002296, 50002297, 50002298, 50002301, 50002302, 50002311, 50001567, 50001612, 50001658, 50002836, 50002873, 50002938, 50002974, 50002975, 50002992, 50002995, 50002997, 50003001, 50003006, 50003007, 50003011, 50003012, 50003016, 50003017, 50003019, 50003020, 50003021, 50003022, 50003024, 50003025, 50003027, 50003038, 50003040, 50003053, 50003064, 50003067, 50003068, 50003074, 50003078, 50002736, 50002990, 50003037, 50003103, 50003131, 50003136, 50003145, 50003146, 50003152, 50003153, 50003155, 50003156, 50003158, 50003162, 50003163, 50003165, 50003171, 50003173, 50003176, 50003177, 50003178, 50003188, 50003189, 50003190, 50003192, 50003193, 50003194, 50003195, 50003197, 50003198, 50003199, 50003203, 50003206, 50003208, 50003209, 50003214, 50003217, 50003218, 50003423, 50003440, 50003455, 50003509, 50003518, 50003534, 50003545, 50003585, 50003605, 50003625, 50003631, 50003645, 50003648, 50003796, 50002876, 50002897, 50003018, 50003028, 50003030, 50003032, 50003044, 50003048, 50003057, 50003070, 50003071, 50003076, 50003077, 50003079, 50003080, 50003083, 50003084, 50003085, 50003088, 50003093, 50003094, 50003095, 50003098, 50003100, 50003101, 50003102, 50003104, 50003105, 50003106, 50003107, 50003108, 50003109, 50003110, 50003111, 50003112, 50003114, 50003115, 50003116, 50003117, 50003118, 50003119, 50003120, 50003121, 50003122, 50003123, 50003124, 50003125, 50003127, 50003128, 50003129, 50003130, 50003132, 50003133, 50003134, 50003135, 50003137, 50003138, 50003139, 50003140, 50003141, 50003142, 50003144, 50003148, 50003149, 50003151, 50003154, 50003159, 50003161, 50003166, 50003168, 50003170, 50003172, 50003175, 50003179, 50003181, 50003182, 50003183, 50003184, 50003185, 50003186, 50003187, 50003191, 50003196, 50003202, 50003205, 50003207, 50003211, 50003212, 50003215, 50003216, 50003219, 50003220, 50003221, 50003222, 50003223, 50003224, 50003225, 50003226, 50003227, 50003228, 50003229, 50003230, 50003231, 50003233, 50003234, 50003235, 50003236, 50003238, 50003239, 50003240, 50003242, 50003243, 50003245, 50003247, 50003248, 50003249, 50003250, 50003251, 50003252, 50003253, 50003254, 50003255, 50003256, 50003258, 50003263, 50003264, 50003265, 50003270, 50003271, 50003273, 50003276, 50003283, 50003284, 50003295, 50003296, 50003297, 50003303, 50003304, 50003306, 50003310, 50003313, 50003314, 50003315, 50003318, 50003320, 50003321, 50003322, 50003323, 50003324, 50003325, 50003326, 50003328, 50003330, 50003332, 50003333, 50003336, 50003337, 50003342, 50003346, 50003349, 50003350, 50003351, 50003353, 50003354, 50003355, 50003356, 50003357, 50003359, 50003361, 50003365, 50003366, 50003367, 50003368, 50003369, 50003370, 50003371, 50003372, 50003373, 50003374, 50003375, 50003377, 50003378, 50003379, 50003380, 50003381, 50003383, 50003385, 50003386, 50003387, 50003388, 50003389, 50003390, 50003392, 50003394, 50003395, 50003396, 50003397, 50003398, 50003399, 50003401, 50003402, 50003404, 50003405, 50003406, 50003407, 50003409, 50003410, 50003411, 50003412, 50003413, 50003414, 50003418, 50003419, 50003420, 50003421, 50003422, 50003427, 50003429, 50003430, 50003435, 50003436, 50003441, 50003449, 50003465, 50003467, 50003473, 50003475, 50003476, 50003477, 50003480, 50003482, 50003484, 50003486, 50003489, 50003490, 50003493, 50003496, 50003499, 50003504, 50003506, 50003507, 50003510, 50003511, 50003516, 50003517, 50003520, 50003527, 50003531, 50003541, 50003553, 50003554, 50003556, 50003559, 50003565, 50003569, 50003574, 50003576, 50003588, 50003591, 50003593, 50003596, 50003597, 50003609, 50003614, 50003619, 50003621, 50003622, 50003626, 50003635, 50003640, 50003642, 50003646, 50003647, 50003649, 50003651, 50003652, 50003653, 50003662, 50003663, 50003667, 50003668, 50003670, 50003672, 50003674, 50003675, 50003678, 50003679, 50003681, 50003683, 50003685, 50003687, 50003692, 50003695, 50003696, 50003698, 50003699, 50003706, 50003712, 50003713, 50003718, 50003719, 50003722, 50003723, 50003726, 50003727, 50003728, 50003734, 50003737, 50003738, 50003740, 50003741, 50003742, 50003745, 50003748, 50003749, 50003751, 50003752, 50003756, 50003761, 50003762, 50003764, 50003765, 50003767, 50003768, 50003775, 50003776, 50003785, 50003786, 50003787, 50003789, 50003793, 50003794, 50003797, 50003798, 50003801, 50003804, 50003807, 50003812, 50003816, 50003817, 50003818, 50003819, 50003820, 50003822, 50003823, 50003824, 50003829, 50003831, 50003832, 50003833, 50003834, 50003836, 50003838, 50003839, 50003840, 50003842, 50003847, 50003848, 50003849, 50003852, 50003853, 50003854, 50003855, 50003856, 50003857, 50003860, 50003863, 50003864, 50003866, 50003868, 50003869, 50003871, 50003875, 50003877, 50003878, 50003880, 50003884, 50003885, 50003886, 50003887, 50003888, 50003889, 50003891, 50003892, 50003893, 50003894, 50003895, 50003896, 50003897, 50003898, 50003899, 50003900, 50003901, 50003902, 50003903, 50003905, 50003906, 50003908, 50003911, 50003912, 50003913, 50003914, 50003916, 50003917, 50003918, 50003919, 50003920, 50003922, 50003923, 50003925, 50003926, 50003927, 50003929, 50003931, 50003934, 50003936, 50003938, 50003940, 50003942, 50003944, 50003945, 50003946, 50003947, 50003948, 50003951, 50003952, 50003953, 50003954, 50003955, 50003956, 50003957, 50003959, 50003960, 50003961, 50003962, 50003963, 50003964, 50003965, 50003966, 50003968, 50003970, 50003971, 50003972, 50003976, 50003977, 50003981, 50003984, 50003985, 50003986, 50003987, 50003989, 50003991, 50003993, 50003994, 50003996, 50003999, 50004001, 50004002, 50004003, 50004004, 50004005, 50004007, 50004008, 50004009, 50004010, 50004011, 50004012, 50004013, 50004014, 50004017, 50004018, 50004019, 50004021, 50004022, 50004024, 50004026, 50004028, 50004029, 50004030, 50004031, 50004032, 50004033, 50004034, 50004035, 50004036, 50004037, 50004038, 50004039, 50004041, 50004042, 50004043, 50004044, 50004045, 50004047, 50004049, 50004050, 50004051, 50004052, 50004053, 50004054, 50004055, 50004056, 50004057, 50004058, 50004059, 50004061, 50004062, 50004063, 50004064, 50004065, 50004067, 50004068, 50004069, 50004071, 50004073, 50004075, 50004076, 50004080, 50004081, 50004082, 50004084, 50004085, 50004086, 50004087, 50004088, 50004089, 50004090, 50004091, 50004092, 50004093, 50004095, 50004096, 50004097, 50004098, 50004101, 50004102, 50004103, 50004104, 50004109, 50004110, 50004112, 50004113, 50004114, 50004115, 50004116, 50004117, 50004118, 50004119, 50004122, 50004123, 50004126, 50004127, 50004129, 50004130, 50004131, 50004134, 50004135, 50004137, 50004138, 50004139, 50004140, 50004142, 50004143, 50004145, 50004147, 50004151, 50004152, 50004153, 50004155, 50004159, 50004162, 50004164, 50004165, 50004169, 50004170, 50004171, 50004172, 50004173, 50004174, 50004175, 50004176, 50004180, 50004186, 50004187, 50004190, 50004192, 50004195, 50004196, 50004199, 50004215, 50004221, 50004231, 50004233, 50004238, 50004239, 50001392, 50001415, 50001427, 50001439, 50001440, 50001448, 50001458, 50001461, 50001474, 50001482, 50001501, 50001505, 50001510, 50001536, 50001544, 50001558, 50001559, 50001562, 50001563, 50001565, 50001574, 50001576, 50001593, 50001600, 50001631, 50002514, 50002575, 50002623, 50002629, 50002646, 50002677, 50002692, 50002722, 50002726, 50002735, 50002742, 50002764, 50002817, 50003004, 50000294, 50000295, 50000296, 50000298, 50000299, 50000303, 50000304, 50000309, 50001694, 50001714, 50001723, 50001739, 50001788, 50001795, 50001812, 50001813, 50001815, 50001818, 50001819, 50001831, 50001840, 50001842, 50001849, 50001859, 50001866, 50001869, 50001871, 50001874, 50001875, 50001876, 50001878, 50001879, 50001884, 50001885, 50001889, 50001892, 50001894, 50001895, 50001899, 50001900, 50001902, 50001903, 50001904, 50001905, 50001906, 50001907, 50001911, 50001920, 50001923, 50001924, 50001925, 50001928, 50001929, 50001930, 50001934, 50001935, 50001938, 50001942, 50001945, 50001950, 50001955, 50001961, 50001963, 50001965, 50001968, 50001971, 50001975, 50001977, 50001979, 50001987, 50001992, 50001996, 50002004, 50002027, 50002034, 50002047, 50002052, 50002071, 50002085, 50002087, 50002091, 50002107, 50002114, 50002120, 50002123, 50002126, 50002128, 50002143, 50002144, 50002148, 50002149, 50002157, 50002166, 50002174, 50002175, 50002177, 50002179, 50002183, 50002186, 50002195, 50002196, 50002198, 50002201, 50002207, 50002209, 50002214, 50002220, 50002222, 50002225, 50002226, 50002227, 50002230, 50002234, 50002236, 50002243, 50002247, 50002249, 50002253, 50002256, 50002258, 50002259, 50002260, 50002262, 50002271, 50002273, 50002295, 50002314, 50002339, 50002351, 50002355, 50002365, 50002375, 50002393, 50002406, 50002415, 50002424, 50002428, 50002431, 50002435, 50002436, 50002438, 50002440, 50002445, 50002448, 50002451, 50002454, 50002458, 50002460, 50002462, 50002463, 50002464, 50002465, 50002466, 50002467, 50002470, 50002472, 50002475, 50002476, 50002477, 50002478, 50002480, 50002482, 50002483, 50002488, 50002489, 50002490, 50002493, 50002494, 50002496, 50002497, 50002498, 50002499, 50002500, 50002501, 50002505, 50002506, 50002507, 50002508, 50002509, 50002510, 50002511, 50002512, 50002513, 50002515, 50002516, 50002517, 50002520, 50002522, 50002523, 50002524, 50002527, 50002528, 50002529, 50002531, 50002532, 50002533, 50002535, 50002536, 50002538, 50002539, 50002540, 50002542, 50002543, 50002545, 50002548, 50002550, 50002551, 50002552, 50002553, 50002554, 50002557, 50002559, 50002560, 50002564, 50002565, 50002566, 50002567, 50002568, 50002570, 50002571, 50002572, 50002573, 50002578, 50002580, 50002583, 50002584, 50002585, 50002586, 50002587, 50002588, 50002589, 50002591, 50002592, 50002594, 50002596, 50002597, 50002600, 50002602, 50002606, 50002608, 50002610, 50002611, 50002613, 50002616, 50002617, 50002621, 50002622, 50002624, 50002628, 50002633, 50002638, 50002640, 50002642, 50002643, 50002645, 50002647, 50002648, 50002653, 50002654, 50002655, 50002656, 50002658, 50002659, 50002660, 50002662, 50002664, 50002665, 50002666, 50002667, 50002668, 50002671, 50002685, 50002686, 50002694, 50002697, 50002699, 50002700, 50002701, 50002703, 50002704, 50002705, 50002706, 50002709, 50002713, 50002714, 50002715, 50002718, 50002719, 50002721, 50002723, 50002724, 50002727, 50002728, 50002729, 50002730, 50002732, 50002733, 50002738, 50002740, 50002741, 50002747, 50002749, 50002752, 50002754, 50002759, 50002760, 50002763, 50002766, 50002767, 50002768, 50002769, 50002771, 50002772, 50002775, 50002776, 50002777, 50002778, 50002779, 50002782, 50002783, 50002785, 50002786, 50002787, 50002789, 50002790, 50002791, 50002793, 50002794, 50002795, 50002796, 50002797, 50002800, 50002802, 50002806, 50002812, 50002813, 50002815, 50002826, 50002829, 50002830, 50002833, 50002838, 50002841, 50002842, 50002849, 50002850, 50002852, 50002854, 50002856, 50002857, 50002859, 50002860, 50002862, 50002863, 50002865, 50002866, 50002867, 50002868, 50002869, 50002870, 50002871, 50002872, 50002875, 50002877, 50002879, 50002880, 50002881, 50002882, 50002883, 50002884, 50002885, 50002886, 50002887, 50002888, 50002890, 50002891, 50002893, 50002894, 50002895, 50002898, 50002899, 50002900, 50002901, 50002902, 50002903, 50002904, 50002905, 50002906, 50002907, 50002908, 50002909, 50002910, 50002911, 50002913, 50002914, 50002915, 50002916, 50002917, 50002918, 50002919, 50002921, 50002923, 50002924, 50002925, 50002926, 50002927, 50002928, 50002929, 50002930, 50002932, 50002933, 50002934, 50002935, 50002936, 50002937, 50002939, 50002940, 50002942, 50002944, 50002947, 50002948, 50002949, 50002950, 50002951, 50002956, 50002958, 50002960, 50002961, 50002962, 50002963, 50002964, 50002965, 50002966, 50002967, 50002968, 50002969, 50002970, 50002971, 50002972, 50002976, 50002977, 50002978, 50002979, 50002980, 50002981, 50002982, 50002986, 50002987, 50002988, 50002989, 50002991, 50002993, 50002994, 50002996, 50002998, 50003003, 50003005, 50003008, 50003010, 50003013, 50003014, 50003073, 50003200; 2) 400021001: UDI/DI 400021001, Serial/Lot Numbers: 50000070; UDI/DI +M335400021, Serial/Lot Numbers: 50000004, 50000005, 50000006, 50000007, 50000008, 50000009, 50000010, 50000011, 50000012, 50000013, 50000014, 50000015, 50000016, 50000017, 50000018, 50000019, 50000020, 50000021, 50000022, 50000023, 50000024, 50000025, 50000026, 50000027, 50000028, 50000029, 50000030, 50000031, 50000032, 50000033, 50000034, 50000035, 50000036, 50000037, 50000038, 50000039, 50000040, 50000041, 50000042, 50000043, 50000044, 50000045, 50000046, 50000047, 50000048, 50000049, 50000050, 50000051, 50000052, 50000053, 50000054, 50000055, 50000056, 50000057, 50000058, 50000059, 50000060, 50000061, 50000062, 50000063, 50000064, 50000065, 50000066, 50000067, 50000068, 50000069, 50000071, 50000072, 50000073, 50000074, 50000075, 50000076, 50000077, 50000078, 50000079, 50000080, 50000081, 50000082, 50000083, 50000084, 50000086, 50000087, 50000088, 50000089, 50000090, 50000091, 50000092, 50000093, 50000094, 50000095, 50000096, 50000097, 50000098, 50000099, 50000100, 50000101, 50000102, 50000103, 50000104, 50000105, 50000106, 50000107, 50000108, 50000109, 50000110, 50000111, 50000112, 50000113, 50000114, 50000115, 50000116, 50000117; 3) 400021003: UDI/DI +M335400021, Serial/Lot Numbers: 80000052, 80000053, 80000054, 80000055, 80000056, 80000057, 80000058, 80000059, 80000060, 80000061, 80000062, 80000063, 80000064, 80000065, 80000066, 80000067, 80000068, 80000069, 80000071, 80000072, 80000073, 80000074, 80000075, 80000076, 80000078, 80000079, 80000080, 80000081, 80000082, 80000083, 80000084, 80000085, 80000086, 80000087, 80000089, 80000090, 80000091, 80000092, 80000093, 80000094, 80000095, 80000096, 80000097, 80000098, 80000099, 80000100, 80000101, 80000102, 80000103, 80000104, 80000024, 80000027, 80000028, 80000030, 80000031, 80000032, 80000034, 80000035, 80000037, 80000038, 80000039, 80000041, 80000042, 80000043, 80000044, 80000045, 80000046, 80000047, 80000048, 80000049, 80000051, 80000001, 80000002, 80000003, 80000006, 80000007, 80000008, 80000009, 80000010, 80000011, 80000012, 80000013, 80000014, 80000015, 80000017, 80000021, 80000022, 80000023, 80000025, 80000026.

Where was it sold?

Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96777

This product is part of a recall event; the main page for the event is Plum Solos recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025	CLASS II	Plum Solos recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

More recalls from ICU Medical

All 663

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

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Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide