Recall archive / FDA device enforcement

Impella RP Flex with SmartAssist; Product Number: 1000323; — FDA record Z-0830-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 12, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Impella RP Flex with SmartAssist; Product Number: 1000323;
Reason: Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 2,364 units
Agency-reported status: Ongoing
Source record identifier: Z-0830-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Product Number: 1000323; UDI-DI: 00813502012811; Serial Numbers: 551121, 551122, 551123, 551124, 551125, 551127, 551128, 551129, 537606, 537610, 537612, 537615, 537607, 537608, 537609, 537613, 537614, 548547, 548548, 548550, 548553, 548554, 548555, 548556, 548552, 548559, 548560, 548561, 548562, 548563, 548564, 548565, 549638, 549640, 549641, 549642, 549643, 548558, 546672, 546675, 546676, 546678, 546679, 546680, 547552, 547556, 547558, 547559, 547560, 546652, 546654, 546656, 546657, 546658, 546659, 547561, 549644, 549646, 549647, 546661, 547563, 547564, 547566, 547567, 547568, 547569, 547570, 547571, 546681, 547189, 547191, 547192, 547193, 547194, 547195, 548827, 548830, 548831, 548834, 548835, 548836, 543714, 543716, 543719, 543720, 543721, 543722, 547169, 547170, 547171, 547172, 547173, 547174, 547188, 548188, 548189, 548196, 545799, 545800, 545801, 545802, 545803, 545804, 548191, 548192, 548193, 548194, 545486, 545488, 545795, 545796, 545797, 529171, 529172, 529174, 529175, 529179, 545475, 545478, 545481, 545482, 545483, 545489, 545490, 545491, 545492, 545494, 539350, 539352, 539353, 539354, 539355, 543274, 543275, 543276, 543277, 543278, 543279, 543282, 529170, 543273, 543283, 543284, 543286, 544125, 544126, 544130, 539356, 539357, 539358, 539359, 539794, 539795, 539797, 539799, 544123, 544124, 544127, 538387, 538388, 538389, 539790, 539791, 539792, 539793, 538381, 538382, 538383, 538384, 538385, 538386, 543285, 543288, 543289, 543292, 535401, 535403, 535404, 535405, 535407, 539820, 539822, 539823, 539824, 539825, 539826, 539829, 535408, 535409, 535410, 537995, 539800, 539801, 539803, 539806, 539809, 528198, 528199, 535421, 535425, 535427, 535428, 537993, 539805, 537992, 539807, 539808, 531407, 531410, 531411, 531413, 537996, 537997, 537999, 528191, 528192, 528193, 528194, 528195, 531414, 531415, 533140, 533141, 533142, 536414, 536415, 536416, 536417, 536418, 536419, 532106, 533074, 533075, 533079, 533134, 533135, 533137, 533138, 533139, 537973, 537974, 537976, 537980, 538376, 544138, 544139, 544140, 538371, 538372, 538375, 538377, 538378, 538380, 539340, 539341, 539344, 539345, 539347, 539348, 536531, 536534, 536535, 536536, 536537, 539784, 533081, 533082, 533083, 539785, 539786, 539788, 539789, 544131, 544132, 544133, 544134, 544135, 544940, 544941, 544942, 544944, 544945, 544947, 544950, 544952, 544954, 544955, 544957, 544958, 518335, 518337, 518338, 518339, 518340, 518341, 518342, 518343, 544948, 544949, 537661, 537663, 537664, 516715A, 518326A, 518328A, 518329A, 518330A, 518332A, 518333A, 516709A, 516712A, 518476A, 518477A, 518479A, 518480A, 518481A, 518482A, 516706A, 516707A, 516708A, 516767A, 516768A, 516769A, 516770A, 516771A, 516773A, 516774A, 518474A, 518475A, 536560, 536563, 536566, 536568, 536711, 537665, 537666, 537667, 537668, 537669, 535272, 535273, 536712, 536713, 536714, 536715, 536717, 536718, 533798, 533800, 533801, 533804, 533805, 535274, 535275, 535276, 535277, 535278, 535279, 531698, 531702, 531703, 531704, 531705, 531706, 533806, 533807, 531707, 535155, 535156, 535157, 535158, 535160, 535162, 535164, 536719, 531425, 531426, 531417, 531418, 531419, 531420, 531421, 535793, 535794, 535796, 535797, 535800, 535761, 535763, 535765, 535767, 535770, 535791, 535792, 535768, 535769, 524385, 526612, 526614, 526615, 526617, 526618, 528640, 528641, 528643, 526611, 529503, 530051, 530052, 530054, 530055, 530056, 530057, 530059, 526609, 526610, 527878, 527879, 527875, 527876, 527877, 529915, 529916, 529919, 529920, 529921, 529922, 529923, 531728, 531730, 531731, 531732, 531733, 531734, 531735, 531736, 533405, 533406, 533407, 533408, 533409, 533410, 533412, 533413, 530680, 530681, 530682, 530684, 530685, 530687, 530688, 530689, 526179, 526185, 533044, 533045, 533046, 533047, 533049, 533520, 533522, 533523, 533524, 533529, 526180, 526181, 526182, 526184, 526186, 526187, 527870, 527871, 527872, 532099, 532100, 532101, 532102, 536392, 536393, 536394, 536396, 536398, 533050, 533051, 533052, 533053, 527945, 527949, 528646, 528647, 528648, 528649, 529726, 529727, 529729, 529730, 529731, 529732, 529733, 529734, 527940, 527941, 527943, 527946, 527947, 527948, 529502, 529505, 529507, 529509, 529500, 529501, 529504, 529506, 529508, 528181, 528184, 528185, 528186, 528187, 528189, 529181, 529182, 529183, 529184, 529185, 529186, 529187, 529188, 529189, 530040, 530041, 530048, 527003, 529071, 529072, 529073, 529074, 529075, 529076, 529077, 530046, 530049, 524378, 524386, 527001, 527002, 527004, 527005, 527006, 527007, 524377, 524379, 524380, 524381, 524383, 524384, 524804, 524807, 524808, 524809, 524810, 524811, 524812, 521358, 524803, 524805, 524806, 521356, 521357, 521360, 521361, 521362, 521363, 521354, 521355, 521359, 525187, 525188, 525189, 525192, 525038, 525039, 525041, 525045, 525046, 525191, 525193, 525194, 525195, 525196, 526620, 526624, 526621, 526623, 526626, 526628, 526619, 521314, 521315, 521316, 521317, 521318, 521320, 521321, 521322, 521323, 521872, 521874, 526173, 526174, 521875, 521876, 521877, 521878, 521879, 521880, 524181, 524182, 524183, 524184, 524185, 525824, 525830, 525833, 526175, 526176, 526177, 526178, 519279, 519282, 519284, 519286, 519287, 519288, 521245, 525825, 525827, 525828, 525831, 525832, 519280, 519281, 519285, 521240, 521241, 521243, 521244, 521246, 521247, 525808, 525809, 526993, 526995, 526996, 526997, 525805, 525806, 525810, 525811, 525812, 526991, 526992, 519997, 525807, 525813, 526990, 519984, 519985, 519986, 519996, 520002, 520003, 519987, 519988, 519989, 519990, 519998, 519999, 520000, 520001, 519991, 519993, 524179, 524180, 522822, 522827, 522829, 522830, 524398, 524400, 524402, 524404, 517972, 517973, 517975, 517976, 517977, 517978, 517979, 517980, 524397, 524401, 524405, 523972, 523973, 523974, 523976, 523977, 523978, 523979, 523980, 523981, 519699, 519701, 522823, 522824, 522825, 517932, 517933, 517934, 517935, 519702, 519703, 519704, 519705, 519706, 519708, 522819, 522820, 522812, 522813, 522814, 522821, 519259, 519260, 521283, 522815, 522816, 522817, 522818, 521282, 521285, 521286, 521280, 521281, 521284, 521287, 519265, 519266, 519267, 519268, 519261, 519262, 519263, 514768, 514769, 514770, 516764, 516765, 519682, 519685, 519686, 519687, 519688, 514762, 514763, 514764, 514765, 514766, 516583, 516578, 516582, 516584, 516585, 514262, 514263, 516576, 516579, 516581, 500457A, 500459A, 500461A, 500462A, 500463A, 500464A, 500466A, 500685A, 500688A, 500734A, 500735A, 500736A, 500738A, 500739A, 500742A, 501001A, 501002A, 500994A, 500995A, 500997A, 500998A, 500999A, 501000A, 516757, 516758, 516759, 516760, 516763, 513149, 513150, 513151, 513152, 514241, 514242, 514243, 514244, 514245, 514246, 514248, 514264, 514265, 514266, 514267, 514268, 514269, 513153, 514782, 514783, 514786, 514789, 513154, 513155, 513156, 513157, 514781, 497569A, 497570A, 501475A, 501476A, 501480A, 501482A, 497568A, 497571A, 497574A, 501473A, 501477A, 501478A, 501479A, 501481A, 503309A, 503310A, 503313A, 503314A, 503316A, 503534A, 503535A, 503536A, 503537A, 503539A, 503540A, 503543A, 505090A, 505091A, 505092A, 505093A, 505094A, 505095A, 505096A, 496788A, 496789A, 496790A, 496791A, 496792A, 496793A, 496795A, 497572A, 497573A, 497575A, 497576A, 497577A, 499008A, 499009A, 499010A, 499011A, 499012A, 499013A, 499014A, 499015A, 499017A, 503315A, 503317A, 497129A, 497133A, 497135A, 497136A, 497137A, 497528A, 497529A, 497530A, 497531A, 497533A, 497535A, 497123A, 497124A, 497125A, 497126A, 497127A, 497130A, 497131A, 497132A, 497534A, 497536A, 497537A, 498591A, 498593A, 498594A, 498595A, 498597A, 498589A, 498590A, 498596A, 498258A, 498259A, 498262A, 498263A, 498266A, 498260A, 498261A, 498264A, 498265A, 498267A, 499938A, 499939A, 499940A, 499941A, 499943A, 499945A, 499947A, 495826A, 495827A, 495828A, 495829A, 497139A, 499944A, 500227A, 500228A, 500229A, 500230A, 495820A, 495824A, 495825A, 499951A, 499952A, 499953A, 499955A, 499957A, 496653A, 496659A, 497541A, 497543A, 499026A, 499948A, 499949A, 499956A, 500222A, 500224A, 500225A, 500226A, 496656A, 497544A, 497545A, 499021A, 499022A, 500223A, 496654A, 496657A, 496658A, 497540A, 497546A, 499018A, 499019A, 516570, 516572, 518984, 518985, 518986, 518987, 518989, 518990, 518991, 518992, 518993, 516573, 516574, 516566, 516567, 516568, 516569, 516513, 516515, 516571, 519669, 519670, 519672, 519673, 519675, 519676, 519677, 519679, 519680, 519681, 516514, 516517, 516519, 516536, 516542, 516544, 516545, 513137, 516692, 516693, 516694, 516695, 516697, 516699, 518429, 518430, 518433, 518435, 518436, 518437, 518438, 518965, 518966, 518967, 518968, 518969, 518970, 518971, 518972, 518973, 514760, 517883, 517888, 512881, 512883, 513129, 513130, 513131, 513132, 513133, 513134, 513136, 517882, 517885, 517887, 517889, 517891, 512812, 512813, 512814, 512815, 512816, 512817, 512818, 512874, 512875, 512876, 512877, 512878, 512879, 512880, 512809, 512810, 512811, 511439, 511461, 511826, 511827, 511828, 513148, 513494, 513497, 513498, 513499, 513501, 513502, 513503, 513139, 513140, 513142, 513143, 513144, 513145, 513146, 513147, 506304, 512760, 512762, 512763, 512767, 512768, 514751, 514752, 514753, 514754, 514755, 514756, 514757, 514758, 514759, 511819, 511820, 511821, 511822, 511823, 511824, 511825, 513604, 513605, 513606, 513607, 513608, 513611, 513612, 513613, 507534, 507535, 507536, 507537, 507538, 507539, 507540, 507542, 507543, 506305, 506306, 506307, 506308, 506309, 506311, 506312, 506313, 512769, 512771, 512772, 512776, 512777, 512773, 512774, 512775, 512778, 514232, 514233, 514234, 514235, 514236, 514237, 513616, 513618, 513619, 513620, 513621, 513623, 514238, 514239, 513614, 513615, 511443, 511830, 511831, 511832, 511833, 511834, 511835, 511836, 511837, 511437, 511440, 511441, 512461, 512462, 512457, 512458, 512459, 512460, 512464, 512465, 512467, 512472, 511435, 512455, 512456, 512469, 512470, 512471, 511434, 511436, 512463, 511444, 511445, 511448, 511451, 511454, 511455, 511456, 511458, 511459, 511460, 511463, 510914, 510915, 510916, 510899, 510900, 510902, 510903, 510905, 510907, 510908, 510909, 510911, 510912, 510913, 511446, 511447, 509348, 509349, 509350, 509351, 509354, 509356, 509357, 509355, 509921, 509922, 509923, 509930, 509924, 509929, 507810, 506536, 507804, 507805, 507806, 507807, 507808, 504771, 504772, 504773, 504775, 504776, 504777, 506529, 506531, 506532, 506535, 504769, 504770, 504018, 504019, 504020, 504021, 507334, 507335, 504015, 504016, 504022, 507330, 507332, 507337, 507811, 504023, 506537, 507338, 507812, 506538, 507329, 510571, 510573, 510574, 510575, 510580, 507604, 507606, 507609, 507611, 507613, 510546, 510547, 510550, 510552, 510554, 510577, 508406, 508409, 508411, 508412, 508413, 500468, 506824, 506825, 506832, 507143, 507144, 510141, 510142, 510143, 510145, 510146, 510147, 510155, 510170, 506827, 506831, 510150, 500470, 500469, 500472, 500475, 507146, 507147, 507148, 500467, 500471, 500473, 500474, 507145, 501658, 501659, 501661, 510151, 510152, 510169, 501660, 501662, 501663, 510157, 510159, 510160, 501664, 501665, 501667, 510162, 510165, 510167, 510168, 501666, 510532, 510526, 510528, 510529, 510530, 510535, 510533, 510534, 509952, 509953, 509958, 509959, 509954, 509957, 506294, 506295, 506298, 506299, 506300, 506301, 506303, 506297, 505731, 505733, 505734, 505735, 505736, 506545, 506546, 505732, 506407, 506409, 506540, 506541, 506542, 506406, 506408, 506539, 506544, 506411, 506412, 506413, 505087, 505088, 505894, 504033, 504429, 504443, 505427, 505431, 504029, 504030, 504031, 504032, 504430, 504432, 504433, 504435, 504442, 504025, 504028, 504438, 504440, 504791, 503837, 504444, 503834, 503892, 501314, 505081, 505085, 505896, 505899, 505900, 505905, 505424, 505902, 505904, 505906, 505907, 505908, 505909, 505911, 505912, 505913, 504024, 504026, 504436, 504437, 504793, 504795, 504796, 504797, 505079, 505428, 505429, 505432, 505433, 501308, 501309, 501310, 501311, 501312, 501316, 501317, 502041, 502042, 502043, 502044, 502046, 503836, 503889, 503890, 503891, 503893, 503894, 503895, 503896, 503897, ...

Label field

Details supplied by the agency

Lot, code or applicability

Product Number: 1000323; UDI-DI: 00813502012811; Serial Numbers: 551121, 551122, 551123, 551124, 551125, 551127, 551128, 551129, 537606, 537610, 537612, 537615, 537607, 537608, 537609, 537613, 537614, 548547, 548548, 548550, 548553, 548554, 548555, 548556, 548552, 548559, 548560, 548561, 548562, 548563, 548564, 548565, 549638, 549640, 549641, 549642, 549643, 548558, 546672, 546675, 546676, 546678, 546679, 546680, 547552, 547556, 547558, 547559, 547560, 546652, 546654, 546656, 546657, 546658, 546659, 547561, 549644, 549646, 549647, 546661, 547563, 547564, 547566, 547567, 547568, 547569, 547570, 547571, 546681, 547189, 547191, 547192, 547193, 547194, 547195, 548827, 548830, 548831, 548834, 548835, 548836, 543714, 543716, 543719, 543720, 543721, 543722, 547169, 547170, 547171, 547172, 547173, 547174, 547188, 548188, 548189, 548196, 545799, 545800, 545801, 545802, 545803, 545804, 548191, 548192, 548193, 548194, 545486, 545488, 545795, 545796, 545797, 529171, 529172, 529174, 529175, 529179, 545475, 545478, 545481, 545482, 545483, 545489, 545490, 545491, 545492, 545494, 539350, 539352, 539353, 539354, 539355, 543274, 543275, 543276, 543277, 543278, 543279, 543282, 529170, 543273, 543283, 543284, 543286, 544125, 544126, 544130, 539356, 539357, 539358, 539359, 539794, 539795, 539797, 539799, 544123, 544124, 544127, 538387, 538388, 538389, 539790, 539791, 539792, 539793, 538381, 538382, 538383, 538384, 538385, 538386, 543285, 543288, 543289, 543292, 535401, 535403, 535404, 535405, 535407, 539820, 539822, 539823, 539824, 539825, 539826, 539829, 535408, 535409, 535410, 537995, 539800, 539801, 539803, 539806, 539809, 528198, 528199, 535421, 535425, 535427, 535428, 537993, 539805, 537992, 539807, 539808, 531407, 531410, 531411, 531413, 537996, 537997, 537999, 528191, 528192, 528193, 528194, 528195, 531414, 531415, 533140, 533141, 533142, 536414, 536415, 536416, 536417, 536418, 536419, 532106, 533074, 533075, 533079, 533134, 533135, 533137, 533138, 533139, 537973, 537974, 537976, 537980, 538376, 544138, 544139, 544140, 538371, 538372, 538375, 538377, 538378, 538380, 539340, 539341, 539344, 539345, 539347, 539348, 536531, 536534, 536535, 536536, 536537, 539784, 533081, 533082, 533083, 539785, 539786, 539788, 539789, 544131, 544132, 544133, 544134, 544135, 544940, 544941, 544942, 544944, 544945, 544947, 544950, 544952, 544954, 544955, 544957, 544958, 518335, 518337, 518338, 518339, 518340, 518341, 518342, 518343, 544948, 544949, 537661, 537663, 537664, 516715A, 518326A, 518328A, 518329A, 518330A, 518332A, 518333A, 516709A, 516712A, 518476A, 518477A, 518479A, 518480A, 518481A, 518482A, 516706A, 516707A, 516708A, 516767A, 516768A, 516769A, 516770A, 516771A, 516773A, 516774A, 518474A, 518475A, 536560, 536563, 536566, 536568, 536711, 537665, 537666, 537667, 537668, 537669, 535272, 535273, 536712, 536713, 536714, 536715, 536717, 536718, 533798, 533800, 533801, 533804, 533805, 535274, 535275, 535276, 535277, 535278, 535279, 531698, 531702, 531703, 531704, 531705, 531706, 533806, 533807, 531707, 535155, 535156, 535157, 535158, 535160, 535162, 535164, 536719, 531425, 531426, 531417, 531418, 531419, 531420, 531421, 535793, 535794, 535796, 535797, 535800, 535761, 535763, 535765, 535767, 535770, 535791, 535792, 535768, 535769, 524385, 526612, 526614, 526615, 526617, 526618, 528640, 528641, 528643, 526611, 529503, 530051, 530052, 530054, 530055, 530056, 530057, 530059, 526609, 526610, 527878, 527879, 527875, 527876, 527877, 529915, 529916, 529919, 529920, 529921, 529922, 529923, 531728, 531730, 531731, 531732, 531733, 531734, 531735, 531736, 533405, 533406, 533407, 533408, 533409, 533410, 533412, 533413, 530680, 530681, 530682, 530684, 530685, 530687, 530688, 530689, 526179, 526185, 533044, 533045, 533046, 533047, 533049, 533520, 533522, 533523, 533524, 533529, 526180, 526181, 526182, 526184, 526186, 526187, 527870, 527871, 527872, 532099, 532100, 532101, 532102, 536392, 536393, 536394, 536396, 536398, 533050, 533051, 533052, 533053, 527945, 527949, 528646, 528647, 528648, 528649, 529726, 529727, 529729, 529730, 529731, 529732, 529733, 529734, 527940, 527941, 527943, 527946, 527947, 527948, 529502, 529505, 529507, 529509, 529500, 529501, 529504, 529506, 529508, 528181, 528184, 528185, 528186, 528187, 528189, 529181, 529182, 529183, 529184, 529185, 529186, 529187, 529188, 529189, 530040, 530041, 530048, 527003, 529071, 529072, 529073, 529074, 529075, 529076, 529077, 530046, 530049, 524378, 524386, 527001, 527002, 527004, 527005, 527006, 527007, 524377, 524379, 524380, 524381, 524383, 524384, 524804, 524807, 524808, 524809, 524810, 524811, 524812, 521358, 524803, 524805, 524806, 521356, 521357, 521360, 521361, 521362, 521363, 521354, 521355, 521359, 525187, 525188, 525189, 525192, 525038, 525039, 525041, 525045, 525046, 525191, 525193, 525194, 525195, 525196, 526620, 526624, 526621, 526623, 526626, 526628, 526619, 521314, 521315, 521316, 521317, 521318, 521320, 521321, 521322, 521323, 521872, 521874, 526173, 526174, 521875, 521876, 521877, 521878, 521879, 521880, 524181, 524182, 524183, 524184, 524185, 525824, 525830, 525833, 526175, 526176, 526177, 526178, 519279, 519282, 519284, 519286, 519287, 519288, 521245, 525825, 525827, 525828, 525831, 525832, 519280, 519281, 519285, 521240, 521241, 521243, 521244, 521246, 521247, 525808, 525809, 526993, 526995, 526996, 526997, 525805, 525806, 525810, 525811, 525812, 526991, 526992, 519997, 525807, 525813, 526990, 519984, 519985, 519986, 519996, 520002, 520003, 519987, 519988, 519989, 519990, 519998, 519999, 520000, 520001, 519991, 519993, 524179, 524180, 522822, 522827, 522829, 522830, 524398, 524400, 524402, 524404, 517972, 517973, 517975, 517976, 517977, 517978, 517979, 517980, 524397, 524401, 524405, 523972, 523973, 523974, 523976, 523977, 523978, 523979, 523980, 523981, 519699, 519701, 522823, 522824, 522825, 517932, 517933, 517934, 517935, 519702, 519703, 519704, 519705, 519706, 519708, 522819, 522820, 522812, 522813, 522814, 522821, 519259, 519260, 521283, 522815, 522816, 522817, 522818, 521282, 521285, 521286, 521280, 521281, 521284, 521287, 519265, 519266, 519267, 519268, 519261, 519262, 519263, 514768, 514769, 514770, 516764, 516765, 519682, 519685, 519686, 519687, 519688, 514762, 514763, 514764, 514765, 514766, 516583, 516578, 516582, 516584, 516585, 514262, 514263, 516576, 516579, 516581, 500457A, 500459A, 500461A, 500462A, 500463A, 500464A, 500466A, 500685A, 500688A, 500734A, 500735A, 500736A, 500738A, 500739A, 500742A, 501001A, 501002A, 500994A, 500995A, 500997A, 500998A, 500999A, 501000A, 516757, 516758, 516759, 516760, 516763, 513149, 513150, 513151, 513152, 514241, 514242, 514243, 514244, 514245, 514246, 514248, 514264, 514265, 514266, 514267, 514268, 514269, 513153, 514782, 514783, 514786, 514789, 513154, 513155, 513156, 513157, 514781, 497569A, 497570A, 501475A, 501476A, 501480A, 501482A, 497568A, 497571A, 497574A, 501473A, 501477A, 501478A, 501479A, 501481A, 503309A, 503310A, 503313A, 503314A, 503316A, 503534A, 503535A, 503536A, 503537A, 503539A, 503540A, 503543A, 505090A, 505091A, 505092A, 505093A, 505094A, 505095A, 505096A, 496788A, 496789A, 496790A, 496791A, 496792A, 496793A, 496795A, 497572A, 497573A, 497575A, 497576A, 497577A, 499008A, 499009A, 499010A, 499011A, 499012A, 499013A, 499014A, 499015A, 499017A, 503315A, 503317A, 497129A, 497133A, 497135A, 497136A, 497137A, 497528A, 497529A, 497530A, 497531A, 497533A, 497535A, 497123A, 497124A, 497125A, 497126A, 497127A, 497130A, 497131A, 497132A, 497534A, 497536A, 497537A, 498591A, 498593A, 498594A, 498595A, 498597A, 498589A, 498590A, 498596A, 498258A, 498259A, 498262A, 498263A, 498266A, 498260A, 498261A, 498264A, 498265A, 498267A, 499938A, 499939A, 499940A, 499941A, 499943A, 499945A, 499947A, 495826A, 495827A, 495828A, 495829A, 497139A, 499944A, 500227A, 500228A, 500229A, 500230A, 495820A, 495824A, 495825A, 499951A, 499952A, 499953A, 499955A, 499957A, 496653A, 496659A, 497541A, 497543A, 499026A, 499948A, 499949A, 499956A, 500222A, 500224A, 500225A, 500226A, 496656A, 497544A, 497545A, 499021A, 499022A, 500223A, 496654A, 496657A, 496658A, 497540A, 497546A, 499018A, 499019A, 516570, 516572, 518984, 518985, 518986, 518987, 518989, 518990, 518991, 518992, 518993, 516573, 516574, 516566, 516567, 516568, 516569, 516513, 516515, 516571, 519669, 519670, 519672, 519673, 519675, 519676, 519677, 519679, 519680, 519681, 516514, 516517, 516519, 516536, 516542, 516544, 516545, 513137, 516692, 516693, 516694, 516695, 516697, 516699, 518429, 518430, 518433, 518435, 518436, 518437, 518438, 518965, 518966, 518967, 518968, 518969, 518970, 518971, 518972, 518973, 514760, 517883, 517888, 512881, 512883, 513129, 513130, 513131, 513132, 513133, 513134, 513136, 517882, 517885, 517887, 517889, 517891, 512812, 512813, 512814, 512815, 512816, 512817, 512818, 512874, 512875, 512876, 512877, 512878, 512879, 512880, 512809, 512810, 512811, 511439, 511461, 511826, 511827, 511828, 513148, 513494, 513497, 513498, 513499, 513501, 513502, 513503, 513139, 513140, 513142, 513143, 513144, 513145, 513146, 513147, 506304, 512760, 512762, 512763, 512767, 512768, 514751, 514752, 514753, 514754, 514755, 514756, 514757, 514758, 514759, 511819, 511820, 511821, 511822, 511823, 511824, 511825, 513604, 513605, 513606, 513607, 513608, 513611, 513612, 513613, 507534, 507535, 507536, 507537, 507538, 507539, 507540, 507542, 507543, 506305, 506306, 506307, 506308, 506309, 506311, 506312, 506313, 512769, 512771, 512772, 512776, 512777, 512773, 512774, 512775, 512778, 514232, 514233, 514234, 514235, 514236, 514237, 513616, 513618, 513619, 513620, 513621, 513623, 514238, 514239, 513614, 513615, 511443, 511830, 511831, 511832, 511833, 511834, 511835, 511836, 511837, 511437, 511440, 511441, 512461, 512462, 512457, 512458, 512459, 512460, 512464, 512465, 512467, 512472, 511435, 512455, 512456, 512469, 512470, 512471, 511434, 511436, 512463, 511444, 511445, 511448, 511451, 511454, 511455, 511456, 511458, 511459, 511460, 511463, 510914, 510915, 510916, 510899, 510900, 510902, 510903, 510905, 510907, 510908, 510909, 510911, 510912, 510913, 511446, 511447, 509348, 509349, 509350, 509351, 509354, 509356, 509357, 509355, 509921, 509922, 509923, 509930, 509924, 509929, 507810, 506536, 507804, 507805, 507806, 507807, 507808, 504771, 504772, 504773, 504775, 504776, 504777, 506529, 506531, 506532, 506535, 504769, 504770, 504018, 504019, 504020, 504021, 507334, 507335, 504015, 504016, 504022, 507330, 507332, 507337, 507811, 504023, 506537, 507338, 507812, 506538, 507329, 510571, 510573, 510574, 510575, 510580, 507604, 507606, 507609, 507611, 507613, 510546, 510547, 510550, 510552, 510554, 510577, 508406, 508409, 508411, 508412, 508413, 500468, 506824, 506825, 506832, 507143, 507144, 510141, 510142, 510143, 510145, 510146, 510147, 510155, 510170, 506827, 506831, 510150, 500470, 500469, 500472, 500475, 507146, 507147, 507148, 500467, 500471, 500473, 500474, 507145, 501658, 501659, 501661, 510151, 510152, 510169, 501660, 501662, 501663, 510157, 510159, 510160, 501664, 501665, 501667, 510162, 510165, 510167, 510168, 501666, 510532, 510526, 510528, 510529, 510530, 510535, 510533, 510534, 509952, 509953, 509958, 509959, 509954, 509957, 506294, 506295, 506298, 506299, 506300, 506301, 506303, 506297, 505731, 505733, 505734, 505735, 505736, 506545, 506546, 505732, 506407, 506409, 506540, 506541, 506542, 506406, 506408, 506539, 506544, 506411, 506412, 506413, 505087, 505088, 505894, 504033, 504429, 504443, 505427, 505431, 504029, 504030, 504031, 504032, 504430, 504432, 504433, 504435, 504442, 504025, 504028, 504438, 504440, 504791, 503837, 504444, 503834, 503892, 501314, 505081, 505085, 505896, 505899, 505900, 505905, 505424, 505902, 505904, 505906, 505907, 505908, 505909, 505911, 505912, 505913, 504024, 504026, 504436, 504437, 504793, 504795, 504796, 504797, 505079, 505428, 505429, 505432, 505433, 501308, 501309, 501310, 501311, 501312, 501316, 501317, 502041, 502042, 502043, 502044, 502046, 503836, 503889, 503890, 503891, 503893, 503894, 503895, 503896, 503897, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Domestic: Nationwide Distribution International: Canada

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 22, 2025
Recall initiation date: Dec 12, 2024
Center classification date: Jan 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records