Use caution Medical device recall · FDA · Published April 22, 2025

ICU Medical Plum Solos Infusion Pump Recall: Software May Bypass Dose Limits

ICU Medical recalls Plum Solos infusion pumps with software version 1.1.1 that may bypass maximum dose limits, risking overdose. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1991-2025Medical device ICU Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835

✎ GovInfoNow plain-language explainer

ICU Medical is recalling certain Plum Solos infusion pumps that may bypass the maximum dose limit alert, potentially leading to overdose. This recall affects specific units with known serial numbers. Read more at govinfonow.com/recall/52433-icu-medical-plum-solos-infusion-pump-recall-software-may-bypass.

Source Summary by GovInfoNow · govinfonow.com/recall/52433-icu-medical-plum-solos-infusion-pump-recall-software-may-bypass · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1991-2025

Cite this page

“ICU Medical Plum Solos Infusion Pump Recall: Software May Bypass Dose Limits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52433-icu-medical-plum-solos-infusion-pump-recall-software-may-bypass. Based on FDA recall #Z-1991-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2025%22&limit=1).

ICU Medical, Inc. recalled ICU Medical Plum Solos infusion pumps on April 22, 2025, according to the FDA. The agency announced that internal testing found a workflow issue in Plum Duo pumps with software version 1.1.1 that may bypass the Maximum Dose Limit alert.

How to tell if you have it

Brand: ICU Medical
Product: ICU Medical Plum Solos infusion pump
Item number: 400011001
Affected devices: Plum Duo pumps with software version 1.1.1
Units affected: 214

The hazard

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 within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA based medication rulesets.

Context

GovInfoNow's records show ICU Medical, Inc. has had 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include Spectrum IQ Infusion Pump Recall (Jan. 13, 2026), Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026), and Medtronic MiniMed 740G Insulin Pump Recall (Feb. 13, 2026).

How to tell if you have this one

Check if your Plum Solos infusion pump has software version 1.1.1. Affected units have specific serial numbers listed in the recall notice.

Brand
ICU Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.

Recall number	Product, codes & lots	Quantity
Z-1990-2025	ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump; 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, 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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, 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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.	1701 units
Z-1991-2025	ICU Medical Plum Solos, Item number 400011001; infusion pump; UDI/DI N/A, Serial/Lot Numbers: 60000001, 60000002, 60000003, 60000005, 60000006, 60000007, 60000008, 60000009, 60000010, 60000011, 60000014, 60000015, 60000016, 60000017, 60000019, 60000020, 60000021, 60000023, 60000024, 60000025, 60000026, 60000027, 60000028, 60000030, 60000032, 60000033, 60000035, 60000038, 60000039, 60000040, 60000041, 60000042, 60000044, 60000045, 60000046, 60000047, 60000048, 60000049, 60000050, 60000051, 60000052, 60000053, 60000054, 60000056, 60000057, 60000058, 60000059, 60000060, 60000061, 60000062, 60000063, 60000064, 60000065, 60000066, 60000067, 60000068, 60000069, 60000070, 60000071, 60000072, 60000073, 60000074, 60000075, 60000076, 60000077, 60000078, 60000079, 60000080, 60000081, 60000082, 60000083, 60000084, 60000085, 60000087, 60000088, 60000089, 60000090, 60000092, 60000093, 60000094, 60000095, 60000096, 60000097, 60000098, 60000099, 60000100, 60000101, 60000102, 60000104, 60000105, 60000107, 60000108, 60000109, 60000110, 60000112, 60000113, 60000114, 60000120, 60000130, 60000133, 60000134, 60000136, 60000139, 60000141, 60000143, 60000147, 60000150, 60000154, 60000159, 60000160, 60000162, 60000165, 60000167, 60000170, 60000171, 60000172, 60000173, 60000174, 60000176, 60000177, 60000178, 60000179, 60000180, 60000183, 60000187, 60000189, 60000190, 60000191, 60000192, 60000198, 60000199, 60000201, 60000203, 60000204, 60000205, 60000206, 60000207, 60000208, 60000209, 60000210, 60000212, 60000213, 60000214, 60000215, 60000216, 60000217, 60000223, 60000224, 60000225, 60000226, 60000227, 60000228, 60000229, 60000230, 60000234, 60000236, 60000237, 60000238, 60000239, 60000240, 60000241, 60000242, 60000244, 60000245, 60000246, 60000247, 60000249, 60000251, 60000252, 60000255, 60000257, 60000259, 60000263, 60000264, 60000265, 60000266, 60000268, 60000269, 60000271, 60000273, 60000274, 60000275, 60000276, 60000277, 60000279, 60000280, 60000281, 60000282, 60000283, 60000284, 60000285, 60000286, 60000288, 60000291, 60000292, 60000295, 60000296, 60000297, 60000298, 60000300, 60000155, 60000193, 60000197, 60000211, 60000243, 60000270, 60000272, 60000123, 60000168, 60000175, 60000195, 60000221, 60000256, 60000294.	214 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your pump's software version; affected units have version 1.1.1.
Contact Manufacturer
Reach out to ICU Medical for guidance on next steps if your pump is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Iowa, Kentucky, Massachusetts, Mississippi, New York, Pennsylvania, Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Apr 22, 2025Firm started the recall
Jun 18, 2025FDA classified it Class II
Jun 25, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the pump immediately?

No immediate stop is required, but affected units should be checked for software version and contacted for guidance.

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Link to this recall

<a href="https://govinfonow.com/recall/52433-icu-medical-plum-solos-infusion-pump-recall-software-may-bypass">ICU Medical Plum Solos Infusion Pump Recall: Software May Bypass Dose Limits (GovInfoNow)</a>

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-1991-2025 (April 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1991-2025 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.