Recall archive / FDA device enforcement

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, ... — FDA record Z-1734-2022

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 11, 2022. 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: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665
Reason: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Classification: Class II
Recalling firm: Exactech, Inc.
Quantity: 7946 devices
Agency-reported status: Ongoing
Source record identifier: Z-1734-2022

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	a. REF 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982; b. REF 130-28-06, GUDID 10885862021922, Serial Numbers: 618681, 618682, 618683, 618686, 618688, 618691, 618693, 618696, 618697, 618698, 618699, 618701, 691919, 691920, 691924, 708701, 708703, 708705, 708706, 708707, 708708, 708709, 786731, 786732, 786733, 786740, 786741, 786742, 786743, 786745, 786746, 786747, 786748, 786751, 786752, 786755, 786756, 786758, 786760, 786761, 786762, 1369855, 1369856, 1369857, 1369858, 1369861; c. REF 130-28-07, GUDID 10885862021939, Serial Numbers: 569785, 569786, 569787, 570965, 570966, 570968, 570970, 570971, 570972, 570973, 570974, 570975, 570976, 570977, 570979, 570980, 570981, 570982, 583427, 583428, 583429, 583430, 583431, 583432, 583434, 583435, 583436, 583437, 583438, 583439, 583441, 583443, 583444, 583445, 583446, 583447, 583448, 583451, 583452, 656293, 656298, 656299, 656302, 656303, 656306, 656307, 656309, 656312, 656314, 712635, 712636, 712637, 712638, 712643, 712644, 712646, 712647, 712650, 712651, 712652, 712657, 712659, 712660, 810722, 810723, 810726, 810727, 810729, 810730, 810731, 810737, 810738, 810739, 810741, 810742, 810743, 810745, 810747, 810748; d. REF 130-28-08, GUDID 10885862021946, Serial Numbers: 625182, 625185, 625186, 625187, 625192, 625193, 625194, 625195, 625196, 625197, 625206, 625207, 690375, 690376, 690378, 690379, 690380, 765865, 765867, 765868, 765877; e. REF 130-28-09, GUDID 10885862021953, Serial Numbers: 620518, 620519, 620520, 620522, 620524, 620525, 620528, 620530, 620532, 620534, 620535, 620536, 620538, 681492, 703321, 703331, 703333, 703338; f. REF 132-22-04, GUDID 10885862022899, Serial Numbers: 622203, 622204, 622205, 622206, 622207, 622208, 622209, 622210, 622211, 622212, 622213, 622214, 622215, 622216, 622217, 622218, 622219, 622220, 622221, 622222, 622223, 622224, 622225, 622226, 622227, 622228, 782728, 782729, 782730, 782731, 782732, 782733, 782734, 782735, 782736, 782737, 782738, 782739, 782740, 782741, 782742, 782743, 782744, 782745, 782746, 782747, 782748, 782749, 782750, 782752, 782753, 782754, 782755, 782756, 782757, 782758, 782759, 954370, 954371, 954372, 954373, 954374, 954375, 954376, 954377, 954378, 954379, 954380, 954381, 954382, 954383, 954384, 954385, 954386, 954387, 954388, 954389, 954390, 954391, 954392, 954393, 954394, 954395, 954396, 954397, 954398, 954399, 954400, 954401, 1061992, 1061993, 1061994, 1061995, 1061996, 1061997, 1061998, 1061999, 1062000, 1062001, 1062002, 1062003, 1062004, 1062005, 1062006, 1062007, 1062008, 1062009, 1062010, 1062011, 1062012, 1062013, 1062014, 1062015, 1062016, 1062017, 1062018, 1062019, 1062020, 1062021, 1062022, 1062023, 1062024, 1062025, 1062026, 1062027, 1062028, 1062029, 1062030, 1062031, 1062032, 1062033, 1062034, 1062035, 1062036, 1062037, 1062038, 1062039, 1062040, 1062041, 1062042, 1062043, 1316908, 1316909, 1316910, 1316911, 1316912, 1316913, 1316914, 1316915, 1316916, 1316917, 1316918, 1316919, 1316920, 1316921, 1316922, 1316923, 1316924, 1316925, 1316926, 1316927, 1359750, 1359751, 1359752, 1359753, 1359754, 1359755, 1359756, 1359757, 1359758, 1359759, 1359760, 1359761, 1359762, 1521378, 1521379, 1521381, 1521382, 1521383, 1521384, 1521385, 1654690, 1654691, 1656126, 1686763, 1686764, 1686765, 1686766, 1686767, 1686768, 1686769, 1686770, 1686771, 1686772, 1686773, 1686774, 1686775, 1686776, 1686777, 1686778, 1686780, 1686781, 1686782, 2040130, 2040131, 2040132, 2040133, 2040134, 2040135, 2040136, 2040137, 2040138, 2040140, 2040141, 2048834, 2048835, 2048836, 2048837, 2173736, 2173737, 2179393, 2188425, 2188426, 2188427, 2198969, 2198970, 2198971, 2198972, 2345255, 2345257, 2345259, 2345261, 2345262, 2345263, 2345264, 2416265, 2416266, 2416267, 2440039, 2440040, 2441288, 2441289, 2441290, 2441291, 2441300, 2441302, 2600716; g. REF 132-22-05, GUDID 10885862022905, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085, 969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059; h. REF 132-22-06, GUDID 10885862022912, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085, 969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059; i. REF 132-22-07, GUDID 10885862022929, Serial Numbers: 955063, 955064, 955068, 955069, 955072, 955073, 955074, 955077, 955078, 955079, 955083, 955085, 955087, 955088, 955091, 955092, 955093, 2255883, 2255884, 2348261, 2348262, 2348264, 2348265, 2348266, 2348267, 2398399, 2398400, 2398402, 2398404, 2398405, 2398406, 2833459; j. REF 132-22-08, GUDID 10885862022936, Serial Numbers: 966436, 966437, 966440, 966447, 966450, 966451, 966452, 966456, 966457, 966459, 1614368, 1614369, 1614370, 1614371, 1614372, 1614373, 1614374, 1614375, 2327263, 2327264, 2392929, 2392930, 2392931, 2392932, 2675707, 2675709, 2675711; k. REF 132-28-05, GUDID 10885862023001, Serial Numbers: 592646, 592647, 592648, 592649, 592650, 592651, 592652, 592653, 592654, 592655, 592657, 602733, 602734, 602735, 602736, 602737, 602738, 602739, 602741, 602742, 602743, 602744, 602745, 602746, 617642, 617643, 617644, 617645, 617646, 617648, 617649, 617650, 617651, 617652, 617653, 617654, 617655, 617656, 617659, 617661, 617662, 617663, 617664, 617665, 647577, 647578, 647579, 647580, 647581, 647582, 647583, 647585, 647586, 647587, 647588, 647589, 647590, 647591, 647592, 647593, 647594, 647597, 647598, 647599, 647601, 647602, 652294, 652297, 652298, 652300, 652301, 652304, 652306, 652307, 652308, 652309, 652310, 652315, 652317, 652318, 665192, 665194, 665195, 665196, 665198, 665199, 665201, 665202, 665203, 665204, 665205, 665206, 665207, 665210, 665212, 685303, 685304, 685305, 685306, 685307, 685308, 685309, 685310, 685312, 685313, 685314, 685316, 685318, 685319, 685321, 685323, 685327, 685328, 685329, 700432, 700436, 700437, 700440, 700442, 700447, 700455, 700457, 700459, 700460, 700461, 700462, 700464, 700465, 700466, 700467, 700468, 700469, 700470, 700471, 700472, 700475, 700476, 700477, 700478, 700480, 700482, 700483, 700484, 700485, 700486, 700487, 700489, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700502, 777001, 777002, 777003, 777004, 777005, 777006, 777007, 777008, 777009, 777010, 777011, 777013, 777014, 777015, 777016, 777017, 777018, 777020, 777021, 777023, 777025, 777026, 777027, 777030, 777031, 810889, 810890, 810892, 810893, 810894, 810896, 810897, 810898, 810900, 810901, 810903, 810904, 810905, 810906, 810907, 810908, 810909, 810910, 810912, 810913, 810915, 810916, 810917, 898467, 898469, 898470, 898475, 898478, 898479, 898480, 898481, 898482, 898483, 898485, 898486, 898487, 898488, 898489, 898490, 898491, 898492, 898493, 898495, 898496, 949430, 949434, 949436, 949439, 949441, 949445, 949447, 949448, 949458, 949460, 949461, 949462, 975898, 975901, 975902, 975903, 975904, 975908, 975912, 1065935, 1065943, 1065952, 1065956, 1065960, 1065961, 1065962, 1229381, 1229383, 1229387, 1229389, 1229390, 1229391, 1229393, 1229394, 1267773, 1267774, 1267775, 1267776, 1267779, 1267780, 1267784, 1267785, 1267788, 1267794, 1267799, 1315265, 1315272, 1315275, 1315276, 1315283, 5021390, 5021393, 5021397, 5021399, 5021400, 5021401, 5021403, 5021405, 5021406, 5021407, 5021408, 5021409, 5021410, 5316432, 5316433, 5316434, 5316435, 5316436, 5316437, 5316438, 5316439, 5316440, 5316441, 5316442, 5316443, 5316444, 5316445, 5316446, 5316447, 5316448, 5316449, 5316450, 5316451, 5448452, 5448454, 5448455, 5448457, 5448459, 5448460, 5448463, 5448465; l. REF 132-28-06, GUDID 10885862023018, Serial Numbers: 569872, 569873, 569874, 569875, 569876, 569878, 569879, 569880, 569881, 569882, 569885, 569886, 569889, 569891, 569892, 569893, 569894, 569895, 581509, 581510, 581511, 581512, 581513, 581514, 581515, 581516, 581523, 581524, 581525, 581526, 581527, 581528, 581529, 581530, 581533, 581534, 581640, 581646, 581647, 581648, 581649, 581652, 581653, 581654, 581655, 581656, 581662, 581666, 581667, 581668, 581669, 581670, 581672, 581673, 581674, 581675, 581676, 581677, 581678, 581679, 581680, 581683, 581684, 581687, 581690, 581691, 581692, 592584, 592585, 592586, 592587, 592588, 592589, 592590, 592591, 592592, 592593, 592594, 592595, 592596, 592597, 592598, 592599, 592600, 592601, 592602, 592603, 592604, 592605, 592698, 592699, 592700, 592701, 592702, 592703, 592704, 592705, 592706, 592707, 592708, 592709, 592710, 592711, 592712, 592713, 592714, 592715, 592716, 592717, 592718, 592719, 592720, 592721, 592722, 592723, 592724, 592725, 592726, 592727, 592728, 592729, 592732, 605920, 605921, 605922, 605923, 605924, 605925, 605926, 605927, 605928, 605929, 605930, 605931, 605933, 605935, 605936, 605937, 605938, 605940, 605942, 605944, 605945, 605946, 605947, 605949, 605950, 605954, 605955, 609451, 609452, 609454, 609458, 609459, 609460, 609461, 609462, 609463, 609464, 609465, 609467, 609468, 609471, 609472, 609473, 609474, 609475, 609477, 609478, 609479, 609480, 614178, 614179, 614184, 614185, 614186, 614187, 614188, 614189, 614190, 614191, 614192, 614194, 614195, 614196, 614198, 617881, 617882, 617883, 617884, 617885, 617889, 617891, 617892, 617893, 617897, 617898, 617899, 617900, 617902, 617903, 617904, 617905, 617906, 617907, 617908, 617909, 617911, 617912, 617913, 617914, 617916, 617917, 617918, 617919, 617920, 617921, 617922, 617923, 617924, 617925, 617926, 617928, 617929, 617930, 617931, 617932, 617933, 617934, 617935, 617936, 617937, 617938, 617939, 617940, 617941, 617942, 617943, 617944, 617946, 626856, 626857, 626858, 626860, 626861, 626862, 626863, 626864, 626865, 626866, 626867, 626868, 626869, 626870, 626871, 626872, 626873, 626874, 626875, 626876, 626877, 626878, 626879, 626880, 626881, 626882, 626883, 626884, 626885, 626886, 626888, 626889, 626890, 626891, 626892, 626893, 626894, 626896, 626897, 626898, 626899, 626900, 626901, 626902, 626903, 626904, 626905, 626906, 626907, 626908, 626909, 626910, 626911, 626912, 626913, 626914, 626915, 626916, 626917, 626918, 626919, 626920, 626921, 626922, 637500, 637501, 637502, 637503, 637504, 637505, 637506, 637507, 637508, 637509, 637510, 637511, 637512, 637513, 637514, 637515, 637516, 637517, 637518, 637519, 637520, 637521, 637522, 637523, 637524, 637525, 637526, 637528, 637529, 637530, 637531, 637532, 637533, 637534, 637535, 637536, 654326, 654327, 654331, 654332, 654333, 654334, 654335, 654336, 654337, 654338, 654339, 654341, 654342, 654347, 654348, 654352, 654356, 654357, 654359, 654366, 654368, 654370, 654371, 654372, 654375, 654377, 654378, 660294, 660295, 660296, 660297, 660298, 660301, 660302, 660305, 660306, 660307, 660308, 660310, 660313, 660314, 660317, 660318, 660319, 660322, 660323, 660324, 660325, 660326, 660327, 660328, 660329, 660330, 660331, 660333, 660334, 660335, 660336, 660337, 660338, 660339, 660340, 660341, 660343, 660345, 660347, 660349, 660353, 660355, 660356, 660360, 660678, 660682, 660683, 660688, 660689, 660692, 660694, 660699, 660700, 660702, 660703, 660704, 660706, 660707, 660708, 660712, 660713, 660717, 660718, 660719, 660722, 660723, 660727, 660728, 660729, 660730, 660733, 660734, 660735, 660736, 667766, 667767, 667768, 667769, 667770, 667771, 667772, 667774, 667775, 667776, 667777, 667778, 667779, 667780, 667781, 667782, 667783, 667784, 667785, 667786, 667787, 667788, 667789, 667790, 667791, 667792, 667793, 667794, 667795, 667796, 667797, 667798, 667799, 667800, 667801, 667802, 667803, 667804, 667805, 667806, 667807, 667808, 667809, 667810, 667811, 667812, 667813, 667814, 667815, 667816, 667817, 667818, 667819, 667820, 667822, 667823, 667824, 667825, 667826, 667827, 667828, 667829, 667830, 667831, 667832, 667833, 667834, 667835, 667836, 667837, 667840, 667841, 667842, 6678...

Label field

Details supplied by the agency

Lot, code or applicability

a. REF 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982; b. REF 130-28-06, GUDID 10885862021922, Serial Numbers: 618681, 618682, 618683, 618686, 618688, 618691, 618693, 618696, 618697, 618698, 618699, 618701, 691919, 691920, 691924, 708701, 708703, 708705, 708706, 708707, 708708, 708709, 786731, 786732, 786733, 786740, 786741, 786742, 786743, 786745, 786746, 786747, 786748, 786751, 786752, 786755, 786756, 786758, 786760, 786761, 786762, 1369855, 1369856, 1369857, 1369858, 1369861; c. REF 130-28-07, GUDID 10885862021939, Serial Numbers: 569785, 569786, 569787, 570965, 570966, 570968, 570970, 570971, 570972, 570973, 570974, 570975, 570976, 570977, 570979, 570980, 570981, 570982, 583427, 583428, 583429, 583430, 583431, 583432, 583434, 583435, 583436, 583437, 583438, 583439, 583441, 583443, 583444, 583445, 583446, 583447, 583448, 583451, 583452, 656293, 656298, 656299, 656302, 656303, 656306, 656307, 656309, 656312, 656314, 712635, 712636, 712637, 712638, 712643, 712644, 712646, 712647, 712650, 712651, 712652, 712657, 712659, 712660, 810722, 810723, 810726, 810727, 810729, 810730, 810731, 810737, 810738, 810739, 810741, 810742, 810743, 810745, 810747, 810748; d. REF 130-28-08, GUDID 10885862021946, Serial Numbers: 625182, 625185, 625186, 625187, 625192, 625193, 625194, 625195, 625196, 625197, 625206, 625207, 690375, 690376, 690378, 690379, 690380, 765865, 765867, 765868, 765877; e. REF 130-28-09, GUDID 10885862021953, Serial Numbers: 620518, 620519, 620520, 620522, 620524, 620525, 620528, 620530, 620532, 620534, 620535, 620536, 620538, 681492, 703321, 703331, 703333, 703338; f. REF 132-22-04, GUDID 10885862022899, Serial Numbers: 622203, 622204, 622205, 622206, 622207, 622208, 622209, 622210, 622211, 622212, 622213, 622214, 622215, 622216, 622217, 622218, 622219, 622220, 622221, 622222, 622223, 622224, 622225, 622226, 622227, 622228, 782728, 782729, 782730, 782731, 782732, 782733, 782734, 782735, 782736, 782737, 782738, 782739, 782740, 782741, 782742, 782743, 782744, 782745, 782746, 782747, 782748, 782749, 782750, 782752, 782753, 782754, 782755, 782756, 782757, 782758, 782759, 954370, 954371, 954372, 954373, 954374, 954375, 954376, 954377, 954378, 954379, 954380, 954381, 954382, 954383, 954384, 954385, 954386, 954387, 954388, 954389, 954390, 954391, 954392, 954393, 954394, 954395, 954396, 954397, 954398, 954399, 954400, 954401, 1061992, 1061993, 1061994, 1061995, 1061996, 1061997, 1061998, 1061999, 1062000, 1062001, 1062002, 1062003, 1062004, 1062005, 1062006, 1062007, 1062008, 1062009, 1062010, 1062011, 1062012, 1062013, 1062014, 1062015, 1062016, 1062017, 1062018, 1062019, 1062020, 1062021, 1062022, 1062023, 1062024, 1062025, 1062026, 1062027, 1062028, 1062029, 1062030, 1062031, 1062032, 1062033, 1062034, 1062035, 1062036, 1062037, 1062038, 1062039, 1062040, 1062041, 1062042, 1062043, 1316908, 1316909, 1316910, 1316911, 1316912, 1316913, 1316914, 1316915, 1316916, 1316917, 1316918, 1316919, 1316920, 1316921, 1316922, 1316923, 1316924, 1316925, 1316926, 1316927, 1359750, 1359751, 1359752, 1359753, 1359754, 1359755, 1359756, 1359757, 1359758, 1359759, 1359760, 1359761, 1359762, 1521378, 1521379, 1521381, 1521382, 1521383, 1521384, 1521385, 1654690, 1654691, 1656126, 1686763, 1686764, 1686765, 1686766, 1686767, 1686768, 1686769, 1686770, 1686771, 1686772, 1686773, 1686774, 1686775, 1686776, 1686777, 1686778, 1686780, 1686781, 1686782, 2040130, 2040131, 2040132, 2040133, 2040134, 2040135, 2040136, 2040137, 2040138, 2040140, 2040141, 2048834, 2048835, 2048836, 2048837, 2173736, 2173737, 2179393, 2188425, 2188426, 2188427, 2198969, 2198970, 2198971, 2198972, 2345255, 2345257, 2345259, 2345261, 2345262, 2345263, 2345264, 2416265, 2416266, 2416267, 2440039, 2440040, 2441288, 2441289, 2441290, 2441291, 2441300, 2441302, 2600716; g. REF 132-22-05, GUDID 10885862022905, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085, 969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059; h. REF 132-22-06, GUDID 10885862022912, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085, 969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059; i. REF 132-22-07, GUDID 10885862022929, Serial Numbers: 955063, 955064, 955068, 955069, 955072, 955073, 955074, 955077, 955078, 955079, 955083, 955085, 955087, 955088, 955091, 955092, 955093, 2255883, 2255884, 2348261, 2348262, 2348264, 2348265, 2348266, 2348267, 2398399, 2398400, 2398402, 2398404, 2398405, 2398406, 2833459; j. REF 132-22-08, GUDID 10885862022936, Serial Numbers: 966436, 966437, 966440, 966447, 966450, 966451, 966452, 966456, 966457, 966459, 1614368, 1614369, 1614370, 1614371, 1614372, 1614373, 1614374, 1614375, 2327263, 2327264, 2392929, 2392930, 2392931, 2392932, 2675707, 2675709, 2675711; k. REF 132-28-05, GUDID 10885862023001, Serial Numbers: 592646, 592647, 592648, 592649, 592650, 592651, 592652, 592653, 592654, 592655, 592657, 602733, 602734, 602735, 602736, 602737, 602738, 602739, 602741, 602742, 602743, 602744, 602745, 602746, 617642, 617643, 617644, 617645, 617646, 617648, 617649, 617650, 617651, 617652, 617653, 617654, 617655, 617656, 617659, 617661, 617662, 617663, 617664, 617665, 647577, 647578, 647579, 647580, 647581, 647582, 647583, 647585, 647586, 647587, 647588, 647589, 647590, 647591, 647592, 647593, 647594, 647597, 647598, 647599, 647601, 647602, 652294, 652297, 652298, 652300, 652301, 652304, 652306, 652307, 652308, 652309, 652310, 652315, 652317, 652318, 665192, 665194, 665195, 665196, 665198, 665199, 665201, 665202, 665203, 665204, 665205, 665206, 665207, 665210, 665212, 685303, 685304, 685305, 685306, 685307, 685308, 685309, 685310, 685312, 685313, 685314, 685316, 685318, 685319, 685321, 685323, 685327, 685328, 685329, 700432, 700436, 700437, 700440, 700442, 700447, 700455, 700457, 700459, 700460, 700461, 700462, 700464, 700465, 700466, 700467, 700468, 700469, 700470, 700471, 700472, 700475, 700476, 700477, 700478, 700480, 700482, 700483, 700484, 700485, 700486, 700487, 700489, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700502, 777001, 777002, 777003, 777004, 777005, 777006, 777007, 777008, 777009, 777010, 777011, 777013, 777014, 777015, 777016, 777017, 777018, 777020, 777021, 777023, 777025, 777026, 777027, 777030, 777031, 810889, 810890, 810892, 810893, 810894, 810896, 810897, 810898, 810900, 810901, 810903, 810904, 810905, 810906, 810907, 810908, 810909, 810910, 810912, 810913, 810915, 810916, 810917, 898467, 898469, 898470, 898475, 898478, 898479, 898480, 898481, 898482, 898483, 898485, 898486, 898487, 898488, 898489, 898490, 898491, 898492, 898493, 898495, 898496, 949430, 949434, 949436, 949439, 949441, 949445, 949447, 949448, 949458, 949460, 949461, 949462, 975898, 975901, 975902, 975903, 975904, 975908, 975912, 1065935, 1065943, 1065952, 1065956, 1065960, 1065961, 1065962, 1229381, 1229383, 1229387, 1229389, 1229390, 1229391, 1229393, 1229394, 1267773, 1267774, 1267775, 1267776, 1267779, 1267780, 1267784, 1267785, 1267788, 1267794, 1267799, 1315265, 1315272, 1315275, 1315276, 1315283, 5021390, 5021393, 5021397, 5021399, 5021400, 5021401, 5021403, 5021405, 5021406, 5021407, 5021408, 5021409, 5021410, 5316432, 5316433, 5316434, 5316435, 5316436, 5316437, 5316438, 5316439, 5316440, 5316441, 5316442, 5316443, 5316444, 5316445, 5316446, 5316447, 5316448, 5316449, 5316450, 5316451, 5448452, 5448454, 5448455, 5448457, 5448459, 5448460, 5448463, 5448465; l. REF 132-28-06, GUDID 10885862023018, Serial Numbers: 569872, 569873, 569874, 569875, 569876, 569878, 569879, 569880, 569881, 569882, 569885, 569886, 569889, 569891, 569892, 569893, 569894, 569895, 581509, 581510, 581511, 581512, 581513, 581514, 581515, 581516, 581523, 581524, 581525, 581526, 581527, 581528, 581529, 581530, 581533, 581534, 581640, 581646, 581647, 581648, 581649, 581652, 581653, 581654, 581655, 581656, 581662, 581666, 581667, 581668, 581669, 581670, 581672, 581673, 581674, 581675, 581676, 581677, 581678, 581679, 581680, 581683, 581684, 581687, 581690, 581691, 581692, 592584, 592585, 592586, 592587, 592588, 592589, 592590, 592591, 592592, 592593, 592594, 592595, 592596, 592597, 592598, 592599, 592600, 592601, 592602, 592603, 592604, 592605, 592698, 592699, 592700, 592701, 592702, 592703, 592704, 592705, 592706, 592707, 592708, 592709, 592710, 592711, 592712, 592713, 592714, 592715, 592716, 592717, 592718, 592719, 592720, 592721, 592722, 592723, 592724, 592725, 592726, 592727, 592728, 592729, 592732, 605920, 605921, 605922, 605923, 605924, 605925, 605926, 605927, 605928, 605929, 605930, 605931, 605933, 605935, 605936, 605937, 605938, 605940, 605942, 605944, 605945, 605946, 605947, 605949, 605950, 605954, 605955, 609451, 609452, 609454, 609458, 609459, 609460, 609461, 609462, 609463, 609464, 609465, 609467, 609468, 609471, 609472, 609473, 609474, 609475, 609477, 609478, 609479, 609480, 614178, 614179, 614184, 614185, 614186, 614187, 614188, 614189, 614190, 614191, 614192, 614194, 614195, 614196, 614198, 617881, 617882, 617883, 617884, 617885, 617889, 617891, 617892, 617893, 617897, 617898, 617899, 617900, 617902, 617903, 617904, 617905, 617906, 617907, 617908, 617909, 617911, 617912, 617913, 617914, 617916, 617917, 617918, 617919, 617920, 617921, 617922, 617923, 617924, 617925, 617926, 617928, 617929, 617930, 617931, 617932, 617933, 617934, 617935, 617936, 617937, 617938, 617939, 617940, 617941, 617942, 617943, 617944, 617946, 626856, 626857, 626858, 626860, 626861, 626862, 626863, 626864, 626865, 626866, 626867, 626868, 626869, 626870, 626871, 626872, 626873, 626874, 626875, 626876, 626877, 626878, 626879, 626880, 626881, 626882, 626883, 626884, 626885, 626886, 626888, 626889, 626890, 626891, 626892, 626893, 626894, 626896, 626897, 626898, 626899, 626900, 626901, 626902, 626903, 626904, 626905, 626906, 626907, 626908, 626909, 626910, 626911, 626912, 626913, 626914, 626915, 626916, 626917, 626918, 626919, 626920, 626921, 626922, 637500, 637501, 637502, 637503, 637504, 637505, 637506, 637507, 637508, 637509, 637510, 637511, 637512, 637513, 637514, 637515, 637516, 637517, 637518, 637519, 637520, 637521, 637522, 637523, 637524, 637525, 637526, 637528, 637529, 637530, 637531, 637532, 637533, 637534, 637535, 637536, 654326, 654327, 654331, 654332, 654333, 654334, 654335, 654336, 654337, 654338, 654339, 654341, 654342, 654347, 654348, 654352, 654356, 654357, 654359, 654366, 654368, 654370, 654371, 654372, 654375, 654377, 654378, 660294, 660295, 660296, 660297, 660298, 660301, 660302, 660305, 660306, 660307, 660308, 660310, 660313, 660314, 660317, 660318, 660319, 660322, 660323, 660324, 660325, 660326, 660327, 660328, 660329, 660330, 660331, 660333, 660334, 660335, 660336, 660337, 660338, 660339, 660340, 660341, 660343, 660345, 660347, 660349, 660353, 660355, 660356, 660360, 660678, 660682, 660683, 660688, 660689, 660692, 660694, 660699, 660700, 660702, 660703, 660704, 660706, 660707, 660708, 660712, 660713, 660717, 660718, 660719, 660722, 660723, 660727, 660728, 660729, 660730, 660733, 660734, 660735, 660736, 667766, 667767, 667768, 667769, 667770, 667771, 667772, 667774, 667775, 667776, 667777, 667778, 667779, 667780, 667781, 667782, 667783, 667784, 667785, 667786, 667787, 667788, 667789, 667790, 667791, 667792, 667793, 667794, 667795, 667796, 667797, 667798, 667799, 667800, 667801, 667802, 667803, 667804, 667805, 667806, 667807, 667808, 667809, 667810, 667811, 667812, 667813, 667814, 667815, 667816, 667817, 667818, 667819, 667820, 667822, 667823, 667824, 667825, 667826, 667827, 667828, 667829, 667830, 667831, 667832, 667833, 667834, 667835, 667836, 667837, 667840, 667841, 667842, 6678...

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 distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

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 21, 2022
Recall initiation date: Aug 11, 2022
Center classification date: Sep 9, 2022

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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