Recall archive / FDA device enforcement

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U — FDA record Z-3123-2024

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 Aug 7, 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: FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Reason: Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.
Classification: Class II
Recalling firm: BioFire Diagnostics, LLC
Quantity: 3,439
Agency-reported status: Ongoing
Source record identifier: Z-3123-2024

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	HTFA-ASY-0003, UDI: 00815381020277, Serial Numbers: KTM01040, KTM03252, KTM05330, KTM05411, KTM05602, KTM05734, KTM05800, KTM05810, KTM05887, KTM05997, KTM06000, KTM06003, KTM06005, KTM06038, KTM06057, KTM06063, KTM06139, KTM06639, KTM06756, KTM06870, KTM06902, KTM07116, KTM13705, KTM13710, KTM13815, KTM14196, KTM14329, KTM14357, KTM14918, KTM15242, KTM15798, KTM15801, KTM15819, KTM17194, KTM17531, KTM17570, KTM17576, KTM17696, KTM17812, KTM18083, KTM18448, KTM18453, KTM18464, KTM18559, KTM19173, KTM19183, KTM19386, KTM20255, KTM20260, KTM20273, KTM20280, KTM20296, KTM20299, KTM20301, KTM20308, KTM20314, KTM20318, KTM20321, KTM20324, KTM20325, KTM20330, KTM20354, KTM20398, KTM20403, KTM20502, KTM13752, KTM18382, KTM19197, KTM19634, KTM19610, KTM20269, KTM21459, KTM00143, KTM00173, KTM00221, KTM00230, KTM00237, KTM01401, KTM01437, KTM01439, KTM01446, KTM00247, KTM07097, KTM07224, KTM07422, KTM09682, KTM10535, KTM10550, KTM12833, KTM13438, KTM14845, KTM18045, KTM15398, KTM01947, KTM04128, KTM05500, KTM05501, KTM06798, KTM06929, KTM08608, KTM08780, KTM08830, KTM08977, KTM10092, KTM10527, KTM11388, KTM11583, KTM11617, KTM11624, KTM11687, KTM12214, KTM12456, KTM12622, KTM12637, KTM13777, KTM13784, KTM14421, KTM14536, KTM15336, KTM15984, KTM16048, KTM16148, KTM16426, KTM16708, KTM16729, KTM17030, KTM17237, KTM17427, KTM20259, KTM20262, KTM20272, KTM20281, KTM20287, KTM20291, KTM20295, KTM20306, KTM20311, KTM20313, KTM20317, KTM20326, KTM20339, KTM20340, KTM20357, KTM17378, KTM20242, KTM03150, KTM20239, KTM20240, KTM20245, KTM20305, KTM02088, KTM20352, KTM18296, KTM04024, KTM04291, KTM04336, KTM04339, KTM15727, KTM01193, KTM03483, KTM03828, KTM03835, KTM03837, KTM04108, KTM05011, KTM05574, KTM05641, KTM05686, KTM06842, KTM06847, KTM06882, KTM07019, KTM07039, KTM07088, KTM07093, KTM07094, KTM07292, KTM07331, KTM07734, KTM07976, KTM07994, KTM08495, KTM08496, KTM10488, KTM13627, KTM13862, KTM16633, KTM16676, KTM16721, KTM17960, KTM17970, KTM18062, KTM19036, KTM19142, KTM19304, KTM20140, KTM20303. HTFA-ASY-0003-W, UDI: 00815381029089, Serial Numbers: KTM00005, KTM00013, KTM00033, KTM00039, KTM00040, KTM00041, KTM00044, KTM00046, KTM00050, KTM00053, KTM00054, KTM00056, KTM00059, KTM00060, KTM00064, KTM00074, KTM00076, KTM00077, KTM00080, KTM00081, KTM00088, KTM00090, KTM00105, KTM00112, KTM00119, KTM00136, KTM00138, KTM00140, KTM00152, KTM00156, KTM00175, KTM00178, KTM00183, KTM00190, KTM00194, KTM00202, KTM00203, KTM00219, KTM00227, KTM00232, KTM00234, KTM00236, KTM00238, KTM00241, KTM00249, KTM00250,KTM00251,KTM00253, KTM00262, KTM00263,KTM00265, KTM00275, KTM00291, KTM00293, KTM00295, KTM00298, KTM00299,KTM00303, KTM00307, KTM00308, KTM00312, KTM00318,KTM00322, KTM00325, KTM00341, KTM00345, KTM00350, KTM00352, KTM00354, KTM00361, KTM00364, KTM00382, KTM00383, KTM00384, KTM00385, KTM00395, KTM00401,KTM00403, KTM00408, KTM00417, KTM00419, KTM00422, KTM00432, KTM00438, KTM00441, KTM00448, KTM00458,KTM00462, KTM00480, KTM00483, KTM00487, KTM00491, KTM00493, KTM00510, KTM00514, KTM00523, KTM00529, KTM00533, KTM00535, KTM00555, KTM00556, KTM00560, KTM00578, KTM00580, KTM00581, KTM00583, KTM00596, KTM00597, KTM00600, KTM00611, KTM00617, KTM00618, KTM00621, KTM00627, KTM00642, KTM00658, KTM00661, KTM00680, KTM00683, KTM00684, KTM00697, KTM00707, KTM00711, KTM00717, KTM00723, KTM00733, KTM00734, KTM00735, KTM00747, KTM00753, KTM00755, KTM00756, KTM00761, KTM00762, KTM00766, KTM00771, KTM00785, KTM00788, KTM00789, KTM00804, KTM00817, KTM00818, KTM00819, KTM00821, KTM00826, KTM00834, KTM00838, KTM00840, KTM00843, KTM00845, KTM00853, KTM00854, KTM00855, KTM00856, KTM00858, KTM00859, KTM00861, KTM00864, KTM00876, KTM00879, KTM00881, KTM00884, KTM00901, KTM00911, KTM00919, KTM00935, KTM00944, KTM00946, KTM00947, KTM00948, KTM00968, KTM00974, KTM00980, KTM00987, KTM00989, KTM00994, KTM00996, KTM00999, KTM009C5, KTM01004, KTM01007, KTM01009, KTM01017, KTM01019, KTM01024, KTM01035, KTM01038, KTM01042, KTM01043, KTM01045, KTM01048, KTM01052, KTM01054, KTM01058, KTM01061, KTM01064, KTM01071, KTM01077, KTM01083, KTM01085, KTM01090, KTM01105, KTM01110, KTM01113, KTM01129, KTM01135, KTM01153, KTM01158, KTM01164, KTM01166, KTM01171, KTM01175, KTM01181, KTM01191, KTM01197, KTM01203, KTM01228, KTM01234, KTM01242, KTM01263, KTM01265, KTM01273, KTM01276, KTM01278, KTM01284, KTM01292, KTM01297, KTM01302, KTM01315, KTM01316, KTM01325, KTM01327, KTM01349, KTM01355, KTM01361, KTM01367, KTM01372, KTM01373, KTM01379, KTM01380, KTM01386, KTM01390, KTM01394, KTM01395, KTM01399, KTM01421, KTM01443, KTM01445, KTM01447, KTM01449, KTM01452, KTM01470, KTM01480, KTM01494, KTM01508, KTM01516, KTM01518, KTM01519, KTM01533, KTM01535, KTM01536, KTM01541, KTM01545, KTM01561, KTM01566, KTM01569, KTM01571, KTM01581, KTM01590, KTM01599, KTM01612, KTM01613, KTM01618, KTM01620, KTM01625, KTM01629, KTM01631, KTM01649, KTM01650, KTM01652, KTM01674, KTM01683, KTM01698, KTM01699, KTM01705, KTM01711, KTM01716, KTM01718, KTM01723, KTM01726, KTM01730, KTM01736, KTM01738, KTM01742, KTM01743, KTM01744, KTM01745, KTM01760, KTM01767, KTM01774, KTM01775, KTM01776, KTM01778, KTM01783, KTM01787, KTM01789, KTM01790, KTM01792, KTM01795, KTM01799, KTM01802, KTM01803, KTM01811, KTM01818, KTM01834, KTM01836, KTM01838, KTM01846, KTM01858, KTM01863, KTM01867, KTM01877, KTM01878, KTM01882, KTM01883, KTM01902, KTM01903, KTM01912, KTM01925, KTM01944, KTM01954, KTM01962, KTM01969, KTM01973, KTM01982, KTM01989, KTM01990, KTM01994, KTM01995, KTM02012, KTM02013, KTM02014, KTM02015, KTM02028, KTM02047, KTM02059, KTM02061, KTM02063, KTM02064, KTM02068, KTM02075, KTM02082, KTM02083, KTM02092, KTM02094, KTM02099, KTM02110, KTM02123, KTM02125, KTM02128, KTM02133, KTM02134, KTM02135, KTM02139, KTM02142, KTM02143, KTM02150, KTM02152, KTM02156, KTM02159, KTM02162, KTM02163, KTM02174, KTM02184, KTM02186, KTM02188, KTM02209, KTM02210, KTM02212, KTM02214, KTM02216, KTM02220, KTM02222, KTM02224, KTM02225, KTM02235, KTM02239, KTM02242, KTM02246, KTM02247, KTM02249, KTM02270, KTM02271, KTM02280, KTM02286, KTM02297, KTM02298, KTM02300, KTM02321, KTM02324, KTM02329, KTM02334, KTM02336, KTM02342, KTM02343, KTM02344, KTM02351, KTM02353, KTM02357, KTM02361, KTM02365, KTM02366, KTM02367, KTM02369, KTM02372, KTM02373, KTM02374, KTM02375, KTM02376, KTM02383, KTM02387, KTM02390, KTM02391, KTM02393, KTM02394, KTM02402, KTM02404, KTM02405, KTM02406, KTM02407, KTM02413, KTM02417, KTM02418, KTM02423, KTM02427, KTM02437, KTM02449, KTM02452, KTM02462, KTM02477, KTM02481, KTM02482, KTM02484, KTM02487, KTM02497, KTM02502, KTM02518, KTM02531, KTM02540, KTM02546, KTM02548, KTM02552, KTM02554, KTM02562, KTM02573, KTM02578, KTM02581, KTM02582, KTM02585, KTM02599, KTM02602, KTM02604, KTM02627, KTM02629, KTM02632, KTM02633, KTM02645, KTM02647, KTM02650, KTM02655, KTM02657, KTM02658, KTM02666, KTM02670, KTM02673, KTM02677, KTM02681, KTM02685, KTM02695, KTM02702, KTM02704, KTM02713, KTM02717, KTM02720, KTM02722, KTM02733, KTM02735, KTM02736, KTM02741, KTM02747, KTM02750, KTM02753, KTM02757, KTM02782, KTM02798, KTM02800, KTM02807, KTM02824, KTM02825, KTM02848, KTM02849, KTM02851, KTM02860, KTM02868, KTM02879, KTM02882, KTM02890, KTM02907, KTM02915, KTM02923, KTM02928, KTM02932, KTM02934, KTM02935, KTM02942, KTM02948, KTM02960, KTM02964, KTM02979, KTM02981, KTM02984, KTM02988, KTM02999, KTM03004, KTM03005, KTM03008, KTM03021, KTM03022, KTM03037, KTM03043, KTM03057, KTM03062, KTM03086, KTM03093, KTM03102, KTM03105, KTM03106, KTM03117, KTM03130, KTM03138, KTM03139, KTM03160, KTM03172, KTM03190, KTM03211, KTM03213, KTM03216, KTM03219, KTM03221, KTM03225, KTM03226, KTM03232, KTM03233, KTM03258, KTM03267, KTM03270, KTM03271, KTM03274,KTM03276, KTM03278, KTM03281, KTM03282, KTM03285, KTM03286, KTM03289, KTM03292, KTM03309, KTM03316, KTM03322, KTM03325, KTM03326, KTM03327, KTM03338, KTM03341, KTM03347, KTM03349, KTM03351, KTM03357, KTM03358, KTM03361, KTM03362, KTM03389, KTM03397, KTM03402, KTM03406, KTM03410, KTM03413, KTM03415, KTM03418, KTM03424, KTM03425, KTM03429, KTM03430, KTM03434, KTM03435, KTM03436, KTM03447, KTM03453, KTM03457, KTM03459, KTM03461, KTM03470, KTM03471, KTM03476, KTM03480, KTM03481, KTM03484, KTM03491, KTM03504, KTM03505, KTM03510, KTM03520, KTM03521, KTM03522, KTM03527, KTM03547, KTM03550, KTM03553, KTM03562, KTM03565, KTM03571, KTM03577, KTM03580, KTM03582, KTM03589, KTM03591, KTM03603, KTM03615, KTM03619, KTM03626, KTM03627, KTM03638, KTM03639, KTM03640, KTM03646, KTM03660, KTM03661, KTM03662, KTM03664, KTM03669, KTM03673, KTM03677, KTM03680, KTM03683, KTM03686, KTM03694, KTM03701, KTM03703, KTM03708, KTM03711, KTM03715, KTM03722, KTM03723, KTM03724, KTM03729, KTM03731, KTM03734, KTM03736, KTM03738, KTM03748, KTM03753, KTM03755, KTM03760, KTM03761, KTM03771, KTM03775, KTM03776, KTM03784, KTM03788, KTM03790, KTM03803, KTM03811, KTM03814, KTM03817, KTM03818, KTM03823, KTM03832, KTM03839, KTM03843, KTM03849, KTM03850, KTM03858, KTM03860, KTM03868, KTM03873, KTM03876, KTM03885, KTM03887, KTM03889, KTM03892, KTM03898, KTM03910, KTM03912, KTM03914, KTM03916, KTM03937, KTM03943, KTM03946, KTM03953, KTM03958, KTM03963, KTM03976, KTM03990, KTM03994, KTM03997, KTM03998, KTM03999, KTM04005, KTM04006, KTM04008, KTM04011, KTM04014, KTM04017, KTM04018, KTM04028, KTM04032, KTM04037, KTM04041, KTM04050, KTM04056, KTM04059, KTM04064, KTM04066, KTM04067, KTM04077, KTM04079, KTM04081, KTM04082, KTM04091, KTM04094, KTM04099, KTM04102, KTM04110, KTM04115, KTM04118, KTM04121, KTM04127, KTM04130, KTM04131, KTM04137, KTM04141, KTM04154, KTM04164, KTM04166, KTM04169, KTM04177, KTM04180, KTM04185, KTM04201, KTM04205, KTM04207, KTM04210, KTM04215, KTM04226, KTM04227, KTM04234, KTM04242, KTM04243, KTM04254, KTM04256, KTM04265, KTM04268, KTM04272, KTM04275, KTM04277, KTM04282, KTM04286, KTM04295, KTM04300, KTM04303, KTM04304, KTM04321, KTM04322, KTM04331, KTM04333, KTM04335, KTM04338, KTM04341, KTM04345, KTM04360, KTM04365, KTM04369, KTM04370, KTM04376, KTM04378, KTM04395, KTM04401, KTM04403, KTM04404, KTM04405, KTM04409, KTM04419, KTM04422, KTM04435, KTM04451, KTM04455, KTM04458, KTM04464, KTM04469, KTM04472, KTM04484, KTM04485, KTM04486, KTM04503, KTM04506, KTM04510, KTM04517, KTM04528, KTM04537, KTM04546, KTM04547, KTM04551, KTM04555, KTM04562, KTM04566, KTM04571, KTM04577, KTM04582, KTM04586, KTM04590, KTM04593, KTM04612, KTM04616, KTM04620, KTM04627, KTM04632, KTM04638, KTM04641, KTM04642, KTM04667, KTM04670, KTM04672, KTM04721, KTM04722, KTM04739, KTM04742, KTM04754, KTM04765, KTM04783, KTM04785, KTM04801, KTM04803, KTM04810, KTM04813, KTM04816, KTM04827, KTM04834, KTM04835, KTM04846, KTM04847, KTM04849, KTM04850, KTM04862, KTM04865, KTM04881, KTM04882, KTM04888, KTM04933, KTM04934, KTM04942, KTM04950, KTM04953, KTM04958, KTM04964, KTM04966, KTM04977, KTM0497A, KTM04981, KTM04982, KTM04988, KTM04989, KTM04991, KTM04994, KTM05002, KTM05004, KTM05005, KTM05007, KTM05008, KTM05019, KTM05021, KTM05034, KTM05038, KTM05039, KTM05040, KTM05048, KTM05052, KTM05058, KTM05062, KTM05070, KTM05077, KTM05081, KTM05088, KTM05090, KTM05097, KTM05098, KTM05107, KTM05112, KTM05113, KTM05119, KTM05124, KTM05126, KTM05131, KTM05132, KTM05138, KTM05140, KTM05143, KTM05144, KTM05155, KTM05186, KTM05194, KTM05195, KTM05214, KTM05219, KTM05222, KTM05225, KTM05228, KTM05229, KTM05235, KTM05240, KTM05244, KTM05255, KTM05260, KTM05265, KTM05267, KTM05270, KTM05281, KTM05289, KTM05290, KTM05303, KTM05304, KTM05307, KTM05311, KTM05316, KTM05319, KTM05326, KTM05327, KTM05328, KTM05338, KTM05352, KTM05357, KTM05369, KTM05371, KTM05373, KTM05375, KTM05385, KTM05389, KTM05395, KTM05396, KTM05421, KTM05424, KTM05435, KTM05442, KTM05451, KTM05453, KTM05454, KTM05467, KTM05468, KTM05470, KTM05493, KTM05494, KTM05504, KTM05507, KTM05517, KTM05519, KTM05521, KTM05522, KTM05526, KTM05529, KTM05535, KTM05536, KTM05541, KTM05549, KTM05552, KTM05554, KTM05555, KTM05561, KTM05567, KTM05571, KTM05576, KTM05579, KTM05582, KTM05584, KTM05597, KTM05604, KTM05623, KTM05628, KTM05630, KTM05635, KTM05638, KTM05676, KTM05677, KTM05683, KTM05687,...

Label field

Details supplied by the agency

Lot, code or applicability

HTFA-ASY-0003, UDI: 00815381020277, Serial Numbers: KTM01040, KTM03252, KTM05330, KTM05411, KTM05602, KTM05734, KTM05800, KTM05810, KTM05887, KTM05997, KTM06000, KTM06003, KTM06005, KTM06038, KTM06057, KTM06063, KTM06139, KTM06639, KTM06756, KTM06870, KTM06902, KTM07116, KTM13705, KTM13710, KTM13815, KTM14196, KTM14329, KTM14357, KTM14918, KTM15242, KTM15798, KTM15801, KTM15819, KTM17194, KTM17531, KTM17570, KTM17576, KTM17696, KTM17812, KTM18083, KTM18448, KTM18453, KTM18464, KTM18559, KTM19173, KTM19183, KTM19386, KTM20255, KTM20260, KTM20273, KTM20280, KTM20296, KTM20299, KTM20301, KTM20308, KTM20314, KTM20318, KTM20321, KTM20324, KTM20325, KTM20330, KTM20354, KTM20398, KTM20403, KTM20502, KTM13752, KTM18382, KTM19197, KTM19634, KTM19610, KTM20269, KTM21459, KTM00143, KTM00173, KTM00221, KTM00230, KTM00237, KTM01401, KTM01437, KTM01439, KTM01446, KTM00247, KTM07097, KTM07224, KTM07422, KTM09682, KTM10535, KTM10550, KTM12833, KTM13438, KTM14845, KTM18045, KTM15398, KTM01947, KTM04128, KTM05500, KTM05501, KTM06798, KTM06929, KTM08608, KTM08780, KTM08830, KTM08977, KTM10092, KTM10527, KTM11388, KTM11583, KTM11617, KTM11624, KTM11687, KTM12214, KTM12456, KTM12622, KTM12637, KTM13777, KTM13784, KTM14421, KTM14536, KTM15336, KTM15984, KTM16048, KTM16148, KTM16426, KTM16708, KTM16729, KTM17030, KTM17237, KTM17427, KTM20259, KTM20262, KTM20272, KTM20281, KTM20287, KTM20291, KTM20295, KTM20306, KTM20311, KTM20313, KTM20317, KTM20326, KTM20339, KTM20340, KTM20357, KTM17378, KTM20242, KTM03150, KTM20239, KTM20240, KTM20245, KTM20305, KTM02088, KTM20352, KTM18296, KTM04024, KTM04291, KTM04336, KTM04339, KTM15727, KTM01193, KTM03483, KTM03828, KTM03835, KTM03837, KTM04108, KTM05011, KTM05574, KTM05641, KTM05686, KTM06842, KTM06847, KTM06882, KTM07019, KTM07039, KTM07088, KTM07093, KTM07094, KTM07292, KTM07331, KTM07734, KTM07976, KTM07994, KTM08495, KTM08496, KTM10488, KTM13627, KTM13862, KTM16633, KTM16676, KTM16721, KTM17960, KTM17970, KTM18062, KTM19036, KTM19142, KTM19304, KTM20140, KTM20303. HTFA-ASY-0003-W, UDI: 00815381029089, Serial Numbers: KTM00005, KTM00013, KTM00033, KTM00039, KTM00040, KTM00041, KTM00044, KTM00046, KTM00050, KTM00053, KTM00054, KTM00056, KTM00059, KTM00060, KTM00064, KTM00074, KTM00076, KTM00077, KTM00080, KTM00081, KTM00088, KTM00090, KTM00105, KTM00112, KTM00119, KTM00136, KTM00138, KTM00140, KTM00152, KTM00156, KTM00175, KTM00178, KTM00183, KTM00190, KTM00194, KTM00202, KTM00203, KTM00219, KTM00227, KTM00232, KTM00234, KTM00236, KTM00238, KTM00241, KTM00249, KTM00250,KTM00251,KTM00253, KTM00262, KTM00263,KTM00265, KTM00275, KTM00291, KTM00293, KTM00295, KTM00298, KTM00299,KTM00303, KTM00307, KTM00308, KTM00312, KTM00318,KTM00322, KTM00325, KTM00341, KTM00345, KTM00350, KTM00352, KTM00354, KTM00361, KTM00364, KTM00382, KTM00383, KTM00384, KTM00385, KTM00395, KTM00401,KTM00403, KTM00408, KTM00417, KTM00419, KTM00422, KTM00432, KTM00438, KTM00441, KTM00448, KTM00458,KTM00462, KTM00480, KTM00483, KTM00487, KTM00491, KTM00493, KTM00510, KTM00514, KTM00523, KTM00529, KTM00533, KTM00535, KTM00555, KTM00556, KTM00560, KTM00578, KTM00580, KTM00581, KTM00583, KTM00596, KTM00597, KTM00600, KTM00611, KTM00617, KTM00618, KTM00621, KTM00627, KTM00642, KTM00658, KTM00661, KTM00680, KTM00683, KTM00684, KTM00697, KTM00707, KTM00711, KTM00717, KTM00723, KTM00733, KTM00734, KTM00735, KTM00747, KTM00753, KTM00755, KTM00756, KTM00761, KTM00762, KTM00766, KTM00771, KTM00785, KTM00788, KTM00789, KTM00804, KTM00817, KTM00818, KTM00819, KTM00821, KTM00826, KTM00834, KTM00838, KTM00840, KTM00843, KTM00845, KTM00853, KTM00854, KTM00855, KTM00856, KTM00858, KTM00859, KTM00861, KTM00864, KTM00876, KTM00879, KTM00881, KTM00884, KTM00901, KTM00911, KTM00919, KTM00935, KTM00944, KTM00946, KTM00947, KTM00948, KTM00968, KTM00974, KTM00980, KTM00987, KTM00989, KTM00994, KTM00996, KTM00999, KTM009C5, KTM01004, KTM01007, KTM01009, KTM01017, KTM01019, KTM01024, KTM01035, KTM01038, KTM01042, KTM01043, KTM01045, KTM01048, KTM01052, KTM01054, KTM01058, KTM01061, KTM01064, KTM01071, KTM01077, KTM01083, KTM01085, KTM01090, KTM01105, KTM01110, KTM01113, KTM01129, KTM01135, KTM01153, KTM01158, KTM01164, KTM01166, KTM01171, KTM01175, KTM01181, KTM01191, KTM01197, KTM01203, KTM01228, KTM01234, KTM01242, KTM01263, KTM01265, KTM01273, KTM01276, KTM01278, KTM01284, KTM01292, KTM01297, KTM01302, KTM01315, KTM01316, KTM01325, KTM01327, KTM01349, KTM01355, KTM01361, KTM01367, KTM01372, KTM01373, KTM01379, KTM01380, KTM01386, KTM01390, KTM01394, KTM01395, KTM01399, KTM01421, KTM01443, KTM01445, KTM01447, KTM01449, KTM01452, KTM01470, KTM01480, KTM01494, KTM01508, KTM01516, KTM01518, KTM01519, KTM01533, KTM01535, KTM01536, KTM01541, KTM01545, KTM01561, KTM01566, KTM01569, KTM01571, KTM01581, KTM01590, KTM01599, KTM01612, KTM01613, KTM01618, KTM01620, KTM01625, KTM01629, KTM01631, KTM01649, KTM01650, KTM01652, KTM01674, KTM01683, KTM01698, KTM01699, KTM01705, KTM01711, KTM01716, KTM01718, KTM01723, KTM01726, KTM01730, KTM01736, KTM01738, KTM01742, KTM01743, KTM01744, KTM01745, KTM01760, KTM01767, KTM01774, KTM01775, KTM01776, KTM01778, KTM01783, KTM01787, KTM01789, KTM01790, KTM01792, KTM01795, KTM01799, KTM01802, KTM01803, KTM01811, KTM01818, KTM01834, KTM01836, KTM01838, KTM01846, KTM01858, KTM01863, KTM01867, KTM01877, KTM01878, KTM01882, KTM01883, KTM01902, KTM01903, KTM01912, KTM01925, KTM01944, KTM01954, KTM01962, KTM01969, KTM01973, KTM01982, KTM01989, KTM01990, KTM01994, KTM01995, KTM02012, KTM02013, KTM02014, KTM02015, KTM02028, KTM02047, KTM02059, KTM02061, KTM02063, KTM02064, KTM02068, KTM02075, KTM02082, KTM02083, KTM02092, KTM02094, KTM02099, KTM02110, KTM02123, KTM02125, KTM02128, KTM02133, KTM02134, KTM02135, KTM02139, KTM02142, KTM02143, KTM02150, KTM02152, KTM02156, KTM02159, KTM02162, KTM02163, KTM02174, KTM02184, KTM02186, KTM02188, KTM02209, KTM02210, KTM02212, KTM02214, KTM02216, KTM02220, KTM02222, KTM02224, KTM02225, KTM02235, KTM02239, KTM02242, KTM02246, KTM02247, KTM02249, KTM02270, KTM02271, KTM02280, KTM02286, KTM02297, KTM02298, KTM02300, KTM02321, KTM02324, KTM02329, KTM02334, KTM02336, KTM02342, KTM02343, KTM02344, KTM02351, KTM02353, KTM02357, KTM02361, KTM02365, KTM02366, KTM02367, KTM02369, KTM02372, KTM02373, KTM02374, KTM02375, KTM02376, KTM02383, KTM02387, KTM02390, KTM02391, KTM02393, KTM02394, KTM02402, KTM02404, KTM02405, KTM02406, KTM02407, KTM02413, KTM02417, KTM02418, KTM02423, KTM02427, KTM02437, KTM02449, KTM02452, KTM02462, KTM02477, KTM02481, KTM02482, KTM02484, KTM02487, KTM02497, KTM02502, KTM02518, KTM02531, KTM02540, KTM02546, KTM02548, KTM02552, KTM02554, KTM02562, KTM02573, KTM02578, KTM02581, KTM02582, KTM02585, KTM02599, KTM02602, KTM02604, KTM02627, KTM02629, KTM02632, KTM02633, KTM02645, KTM02647, KTM02650, KTM02655, KTM02657, KTM02658, KTM02666, KTM02670, KTM02673, KTM02677, KTM02681, KTM02685, KTM02695, KTM02702, KTM02704, KTM02713, KTM02717, KTM02720, KTM02722, KTM02733, KTM02735, KTM02736, KTM02741, KTM02747, KTM02750, KTM02753, KTM02757, KTM02782, KTM02798, KTM02800, KTM02807, KTM02824, KTM02825, KTM02848, KTM02849, KTM02851, KTM02860, KTM02868, KTM02879, KTM02882, KTM02890, KTM02907, KTM02915, KTM02923, KTM02928, KTM02932, KTM02934, KTM02935, KTM02942, KTM02948, KTM02960, KTM02964, KTM02979, KTM02981, KTM02984, KTM02988, KTM02999, KTM03004, KTM03005, KTM03008, KTM03021, KTM03022, KTM03037, KTM03043, KTM03057, KTM03062, KTM03086, KTM03093, KTM03102, KTM03105, KTM03106, KTM03117, KTM03130, KTM03138, KTM03139, KTM03160, KTM03172, KTM03190, KTM03211, KTM03213, KTM03216, KTM03219, KTM03221, KTM03225, KTM03226, KTM03232, KTM03233, KTM03258, KTM03267, KTM03270, KTM03271, KTM03274,KTM03276, KTM03278, KTM03281, KTM03282, KTM03285, KTM03286, KTM03289, KTM03292, KTM03309, KTM03316, KTM03322, KTM03325, KTM03326, KTM03327, KTM03338, KTM03341, KTM03347, KTM03349, KTM03351, KTM03357, KTM03358, KTM03361, KTM03362, KTM03389, KTM03397, KTM03402, KTM03406, KTM03410, KTM03413, KTM03415, KTM03418, KTM03424, KTM03425, KTM03429, KTM03430, KTM03434, KTM03435, KTM03436, KTM03447, KTM03453, KTM03457, KTM03459, KTM03461, KTM03470, KTM03471, KTM03476, KTM03480, KTM03481, KTM03484, KTM03491, KTM03504, KTM03505, KTM03510, KTM03520, KTM03521, KTM03522, KTM03527, KTM03547, KTM03550, KTM03553, KTM03562, KTM03565, KTM03571, KTM03577, KTM03580, KTM03582, KTM03589, KTM03591, KTM03603, KTM03615, KTM03619, KTM03626, KTM03627, KTM03638, KTM03639, KTM03640, KTM03646, KTM03660, KTM03661, KTM03662, KTM03664, KTM03669, KTM03673, KTM03677, KTM03680, KTM03683, KTM03686, KTM03694, KTM03701, KTM03703, KTM03708, KTM03711, KTM03715, KTM03722, KTM03723, KTM03724, KTM03729, KTM03731, KTM03734, KTM03736, KTM03738, KTM03748, KTM03753, KTM03755, KTM03760, KTM03761, KTM03771, KTM03775, KTM03776, KTM03784, KTM03788, KTM03790, KTM03803, KTM03811, KTM03814, KTM03817, KTM03818, KTM03823, KTM03832, KTM03839, KTM03843, KTM03849, KTM03850, KTM03858, KTM03860, KTM03868, KTM03873, KTM03876, KTM03885, KTM03887, KTM03889, KTM03892, KTM03898, KTM03910, KTM03912, KTM03914, KTM03916, KTM03937, KTM03943, KTM03946, KTM03953, KTM03958, KTM03963, KTM03976, KTM03990, KTM03994, KTM03997, KTM03998, KTM03999, KTM04005, KTM04006, KTM04008, KTM04011, KTM04014, KTM04017, KTM04018, KTM04028, KTM04032, KTM04037, KTM04041, KTM04050, KTM04056, KTM04059, KTM04064, KTM04066, KTM04067, KTM04077, KTM04079, KTM04081, KTM04082, KTM04091, KTM04094, KTM04099, KTM04102, KTM04110, KTM04115, KTM04118, KTM04121, KTM04127, KTM04130, KTM04131, KTM04137, KTM04141, KTM04154, KTM04164, KTM04166, KTM04169, KTM04177, KTM04180, KTM04185, KTM04201, KTM04205, KTM04207, KTM04210, KTM04215, KTM04226, KTM04227, KTM04234, KTM04242, KTM04243, KTM04254, KTM04256, KTM04265, KTM04268, KTM04272, KTM04275, KTM04277, KTM04282, KTM04286, KTM04295, KTM04300, KTM04303, KTM04304, KTM04321, KTM04322, KTM04331, KTM04333, KTM04335, KTM04338, KTM04341, KTM04345, KTM04360, KTM04365, KTM04369, KTM04370, KTM04376, KTM04378, KTM04395, KTM04401, KTM04403, KTM04404, KTM04405, KTM04409, KTM04419, KTM04422, KTM04435, KTM04451, KTM04455, KTM04458, KTM04464, KTM04469, KTM04472, KTM04484, KTM04485, KTM04486, KTM04503, KTM04506, KTM04510, KTM04517, KTM04528, KTM04537, KTM04546, KTM04547, KTM04551, KTM04555, KTM04562, KTM04566, KTM04571, KTM04577, KTM04582, KTM04586, KTM04590, KTM04593, KTM04612, KTM04616, KTM04620, KTM04627, KTM04632, KTM04638, KTM04641, KTM04642, KTM04667, KTM04670, KTM04672, KTM04721, KTM04722, KTM04739, KTM04742, KTM04754, KTM04765, KTM04783, KTM04785, KTM04801, KTM04803, KTM04810, KTM04813, KTM04816, KTM04827, KTM04834, KTM04835, KTM04846, KTM04847, KTM04849, KTM04850, KTM04862, KTM04865, KTM04881, KTM04882, KTM04888, KTM04933, KTM04934, KTM04942, KTM04950, KTM04953, KTM04958, KTM04964, KTM04966, KTM04977, KTM0497A, KTM04981, KTM04982, KTM04988, KTM04989, KTM04991, KTM04994, KTM05002, KTM05004, KTM05005, KTM05007, KTM05008, KTM05019, KTM05021, KTM05034, KTM05038, KTM05039, KTM05040, KTM05048, KTM05052, KTM05058, KTM05062, KTM05070, KTM05077, KTM05081, KTM05088, KTM05090, KTM05097, KTM05098, KTM05107, KTM05112, KTM05113, KTM05119, KTM05124, KTM05126, KTM05131, KTM05132, KTM05138, KTM05140, KTM05143, KTM05144, KTM05155, KTM05186, KTM05194, KTM05195, KTM05214, KTM05219, KTM05222, KTM05225, KTM05228, KTM05229, KTM05235, KTM05240, KTM05244, KTM05255, KTM05260, KTM05265, KTM05267, KTM05270, KTM05281, KTM05289, KTM05290, KTM05303, KTM05304, KTM05307, KTM05311, KTM05316, KTM05319, KTM05326, KTM05327, KTM05328, KTM05338, KTM05352, KTM05357, KTM05369, KTM05371, KTM05373, KTM05375, KTM05385, KTM05389, KTM05395, KTM05396, KTM05421, KTM05424, KTM05435, KTM05442, KTM05451, KTM05453, KTM05454, KTM05467, KTM05468, KTM05470, KTM05493, KTM05494, KTM05504, KTM05507, KTM05517, KTM05519, KTM05521, KTM05522, KTM05526, KTM05529, KTM05535, KTM05536, KTM05541, KTM05549, KTM05552, KTM05554, KTM05555, KTM05561, KTM05567, KTM05571, KTM05576, KTM05579, KTM05582, KTM05584, KTM05597, KTM05604, KTM05623, KTM05628, KTM05630, KTM05635, KTM05638, KTM05676, KTM05677, KTM05683, KTM05687,...

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

Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK, WY, IN, NJ, NM, ID, OR, MS, SD, MI, MT, GA, HI, NV, MD, MA, AR, NH, PR, ND, VT, CT, AK, ME, RI and the countries of Korea, Canada, Singapore distributors, Canada, Canada, China, China, Singapore, Canada, China, Mexico, Japan, Chile, Chile, Singapore, Mexico, Hong King, China, Chile, Singapore, Philippines, Korea, Chile, Korea, Australia, Greece.

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: Sep 18, 2024
Recall initiation date: Aug 7, 2024
Center classification date: Sep 11, 2024

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

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