Cook Inc. Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32 Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32
Brand
Cook Inc.
Lot Codes / Batch Numbers
9221784, 9228731, 9232249, 9246529, 9272685, 9272835, 9276029, 9276400, 9303245, 9373623, 9406776, 9466908, 9506559, 9525188, 9557569, 9566160, 9566211, 9575380, 9620378, 9620379, 9620382, 9625916, 9625917, 9636371, 9640584, 9663986 9406777, 9522416, 9566161, 9575382, 9625918, 9656992 9557570, 9566162, 9575383, 9625919, 9625920, 9656978 9221629, 9232247, 9276401, 9303246, 9373624, 9394051, 9403262, 9406778, 9406779, 9406780, 9453299, 9466909, 9466910, 9482147, 9486290, 9486313, 9506616, 9522418, 9522419, 9525189, 9529047, 9534284, 9555442, 9555453, 9555475, 9566214, 9572229, 9575386, 9592482, 9592485, 9594196, 9594205, 9609105, 9617443, 9617445, 9625921, 9625922, 9625923, 9636298, 9636330, 9640585, 9642977, 9650113, 9650114, 9394051X, NS9584273, NS9584274, NS9584275, NS9584276, NS9584277, NS9584278, NS9584279, NS9584280, NS9584281, NS9584282 9214951, 9221781, 9221785, 9221786, 9221787, 9228739, 9232238, 9232239, 9232250, 9234942, 9239302, 9239303, 9246530, 9272665, 9272686, 9272687, 9272836, 9276402, 9276403, 9391303, 9403123, 9403124, 9403125, 9403126, 9403127, 9403128, 9403129, 9403130, 9403131, 9403132, 9403133, 9403134, 9403136, 9403137, 9403138, 9403139, 9404632, 9404633, 9406719, 9406720, 9406721, 9406781, 9406782, 9406783, 9464235, 9522423, 9529049, 9529050, 9529051, 9557572, 9561001, 9566215, 9575388, 9581884, 9594197, 9594206, 9598741, 9602905, 9605694, 9605695, 9625893, 9625896, 9625924, 9625925, 9625926, 9636372, 9640586, 9642978, 9656979, 9656994, 9272665X, 9403130X, 9522423X, NS9239300, NS9239301 9221788, 9289544, 9373625, 9406785, 9419801, 9482149, 9515085, 9557563, 9557573, 9561002, 9566216, 9572230, 9575390, 9594207, 9602906, 9605689, 9605696, 9611316, 9617447, 9620383, 9625897, 9625927, 9625928, 9629883, 9629884, 9640587, 9640588, 9653876, 9656980, 9671098 9228740, 9242449, 9386592, 9386660, 9386661, 9386662, 9466913, 9466914, 9466915, 9605686, 9623874, 9623879, 9625845, 9640513, 9640514, 9671040, 9671042, 9671043, 9671044, 9242450 9228741, 9228742, 9403263, 9419802, 9470240, 9506618, 9515086, 9557574, 9561003, 9566217, 9575392, 9609106, 9623930, 9625929, 9629885, 9640589, 9640590, 9656981, 9660204, 9663989 9373626, 9557564, 9557575, 9569073, 9575332, 9578369, 9629871, 9629886, 9640591, 9656995, 9373626X 8405214, 9221798, 9221799, 9226415, 9226416, 9226417, 9228743, 9232252, 9239304, 9242451, 9248832, 9248833, 9248834, 9276031, 9276032, 9276406, 9276407, 9276408, 9276409, 9303242, 9373627, 9373628, 9409576, 9419022, 9442622, 9464237, 9470243, 9470244, 9470245, 9482150, 9486314, 9486315, 9508711, 9508712, 9508713, 9515058, 9515059, 9515060, 9515088, 9515089, 9515090, 9515091, 9515092, 9522430, 9522431, 9522432, 9522433, 9529053, 9529054, 9557576, 9557577, 9566163, 9569089, 9578373, 9581886, 9584296, 9602907, 9602908, 9602909, 9602910, 9602911, 9617436, 9617449, 9617451, 9617453, 9617455, 9617458, 9620384, 9625898, 9629838, 9629839, 9629872, 9629873, 9629874, 9629875, 9629876, 9629887, 9629888, 9636331, 9636332, 9636333, NS9584286, NS9584287, NS9584288, NS9584289, NS9584290, NS9584291, NS9584292, NS9584293, NS9584294, NS9584295 9226360, 9226418, 9226420, 9226421, 9226422, 9226424, 9226425, 9226426, 9226427, 9228744, 9228745, 9228827, 9232253, 9239284, 9242433, 9242452, 9242453, 9242454, 9242455, 9242456, 9246532, 9246533, 9246534, 9246535, 9246536, 9386666, 9391304, 9391324, 9391325, 9391326, 9391327, 9391454, 9391455, 9391456, 9394052, 9394053, 9403264, 9403265, 9403266, 9419025, 9419026, 9419027, 9456698, 9464238, 9470209, 9470211, 9470246, 9470247, 9470248, 9474588, 9474589, 9474590, 9478694, 9478695, 9482116, 9486316, 9486324, 9506565, 9506566, 9506567, 9506568, 9508715, 9508716, 9508717, 9508718, 9508719, 9508720, 9508721, 9508722, 9512198, 9517953, 9517954, 9525193, 9525194, 9529058, 9529060, 9561004, 9569074, 9569095, 9575333, 9578381, 9598744, 9598745, 9598747, 9602912, 9602913, 9605697, 9623931, 9625899, 9629877, 9629889, 9640556, 9640557, 9640592, 9640593, 9640594, 9640595, 9640596, 9640597, 9640598, 9640599, 9642979, 9642980, 9647086, 9647087, 9650115, 9656963, 9656982, 9228745X, 9391324X, 9470248X, NS9584297, NS9584298, NS9584299, NS9584300, NS9584301, NS9584302, NS9584303, NS9584304, NS9584305, NS9584306 9228746, 9228748, 9232388, 9246537, 9246538, 9246539, 9246540, 9300906, 9303247, 9303248, 9303249, 9303281, 9370215, 9373476, 9373636, 9373638, 9391459, 9391460, 9391461, 9391462, 9403267, 9419029, 9419030, 9419031, 9419032, 9419033, 9419804, 9474595, 9486326, 9486327, 9486328, 9515098, 9515099, 9515100, 9515101, 9522445, 9522446, 9522447, 9522448, 9522449, 9529061, 9529062, 9529064, 9561005, 9566164, 9578386, 9581891, 9581892, 9587377, 9587406, 9647037, 9650044, 9650045, 9373637X 9217948, 9217949, 9217950, 9226365, 9228749, 9228750, 9246541, 9246542, 9246543, 9248835, 9248836, 9373644, 9391463, 9391464, 9394054, 9394055, 9403268, 9403269, 9403270, 9474596, 9525196, 9529066, 9529067, 9529068, 9534296, 9534297, 9557578, 9602871, 9650039, 9650040 9232389, 9246544, 9525197, 9525198, 9566166, 9578388, 9587407, 9625900, 9629891, 9640558, 9642981 9228753, 9232390, 9248837, 9396561, 9525171, 9525200, 9525202, 9557579, 9566167, 9578390, 9594198, 9594209, 9594210, 9629892, 9629893, 9640600, 9642982, 9642983, 9660205, 9664012 9226366, 9228755, 9228756, 9246545, 9246546, 9246547, 9246548, 9272837, 9276416, 9276417, 9300916, 9370209, 9370220, 9370221, 9370222, 9391465, 9391466, 9391467, 9464239, 9474597, 9474598, 9486330, 9506569, 9508723, 9508724, 9508725, 9529069, 9529070, 9566168, 9569103, 9569104, 9569105, 9578391, 9578392, 9581895, 9581896, 9581897, 9584308, 9584309, 9587408, 9598750, 9598751, 9602914, 9611317, 9617464, 9617466, 9617468, 9623932, 9625894, 9625901, 9629894, 9629895, 9629896, 9629897, 9629898, 9640559, 9640560, 9642967, 9642984, 9642985, 9642986, 9642987, 9642988, 9650116, 9653828, 9653858, 9653877, 9653878, 9653879, 9653880, 9656983 9217952, 9228734, 9228828, 9228829, 9228830, 9228831, 9228832, 9228833, 9228834, 9228835, 9228836, 9228837, 9232391, 9232392, 9234943, 9246549, 9246550, 9248838, 9279007, 9300908, 9300913, 9300917, 9303251, 9303283, 9303284, 9370225, 9380032, 9391468, 9391469, 9394056, 9394185, 9394186, 9394187, 9403271, 9403272, 9403273, 9403274, 9403275, 9409622, 9409623, 9419805, 9419807, 9456708, 9456713, 9470212, 9474599, 9474748, 9474749, 9474750, 9474751, 9474752, 9474753, 9506570, 9506571, 9506572, 9508726, 9508727, 9508728, 9508729, 9508730, 9508731, 9508732, 9508733, 9515108, 9515109, 9515110, 9515111, 9515112, 9515113, 9515114, 9525207, 9525208, 9525210, 9557580, 9620332, 9640511, 9642954, 9642955, 9650041, 9671028, 9394185X 9217983, 9217984, 9228735, 9228838, 9228839, 9228840, 9228841, 9228842, 9228843, 9232393, 9232394, 9248839, 9248840, 9272838, 9383423, 9394035, 9394190, 9394191, 9394192, 9394193, 9394194, 9394195, 9396562, 9404637, 9404638, 9404639, 9404640, 9404641, 9447170, 9464240, 9470213, 9470214, 9470215, 9470216, 9474754, 9474755, 9474756, 9474757, 9474758, 9474759, 9482118, 9508734, 9508735, 9515115, 9515116, 9515117, 9515118, 9515119, 9525214, 9525216, 9525218, 9525220, 9525221, 9529071, 9529072, 9529073, 9529074, 9529075, 9557581, 9566170, 9569110, 9572234, 9578357, 9578394, 9578395, 9578396, 9578397, 9578398, 9578399, 9578400, 9581898, 9581899, 9581900, 9587409, 9594199, 9594211, 9594212, 9594213, 9594214, 9594215, 9594216, 9598726, 9598727, 9598752, 9602915, 9602916, 9602917, 9602918, 9602919, 9602920, 9602921, 9609107, 9609108, 9611318, 9617479, 9617481, 9617483, 9617485, 9617488, 9625902, 9629899, 9629900, 9629901, 9629902, 9629903, 9629904, 9629905, 9629906, 9633300, 9633301, 9636334, 9636335, 9640561, 9642989, 9642990, 9642991, 9642992, 9642993, 9647088, 9647089, 9647090, 9647091, 9647092, 9650117, 9650118, 9650119, 9653859, 9653874, 9653881, 9656984, 9671059, 9671101, 9671102, 9671103, 9671104 9370226, 9376518, 9386593, 9386594, 9394036, 9394037, 9394197, 9394198, 9394199, 9394200, 9394201, 9394202, 9470217, 9470218, 9478696, 9478697, 9486297, 9508741, 9512199, 9515122, 9515123, 9515124, 9522377, 9525227, 9525229, 9525231, 9525233, 9529077, 9529078, 9529079, 9561008, 9566171, 9569113, 9578405, 9587415, 9594217, 9602922, 9602923, 9602924, 9605698, 9605699, 9605701, 9605702, 9609109, 9611319, 9617490, 9620385, 9620386, 9623933, 9629878, 9629907, 9636336, 9636337, 9636338, 9640562, 9640563, 9642968, 9642994, 9642995, 9647093, 9650120, 9660206, 9660207, 9660208, 9660209, 9660210 9279021, 9279022, 9279023, 9279024, 9394203, 9522378, 9529009, 9560984, 9561009, 9566172, 9569116, 9575338, 9578408, 9587417, 9594218, 9605703, 9609099, 9609110, 9611320, 9620387, 9620388, 9629908, 9636339, 9640564, 9642969, 9642996, 9642997, 9650121, 9650122, 9653882, 9656985, 9671105, 9671106, 9370227, 9370227X 9279025, 9370228, 9370229, 9400627, 9508744, 9515126, 9515127, 9534247, 9557565, 9560985, 9566173, 9575339, 9578409, 9578411, 9581849, 9587419, 9620389, 9633333, 9642970, 9647072, 9647095, 9650123, 9650124, 9656964, 9330485, 9330485X 9279026, 9279027, 9386653, 9478700, 9482119, 9486299, 9508745, 9508746, 9508747, 9515128, 9515129, 9515130, 9515131, 9522379, 9525248, 9534303, 9534304, 9566174, 9566175, 9569119, 9569122, 9569123, 9578412, 9578413, 9578414, 9578415, 9578416, 9578417, 9578418, 9587421, 9587422, 9594219, 9598729, 9602925, 9602926, 9602927, 9602928, 9602930, 9605704, 9623925, 9623926, 9623934, 9623935, 9623936, 9623937, 9633334, 9636299, 9636340, 9636341, 9636342, 9636343, 9640565, 9640566, 9647073, 9647074, 9647097, 9647098, 9647099, 9647100, 9656986, 9515130X 9276033, 9276034, 9279028, 9279110, 9279118, 9279119, 9279121, 9279122, 9279123, 9279124, 9279125, 9279126, 9279127, 9365243, 9365244, 9365245, 9370230, 9370231, 9370232, 9370238, 9370239, 9370240, 9370241, 9370242, 9386654, 9461549, 9461553, 9464246, 9466882, 9470221, 9470222, 9474577, 9474578, 9478701, 9478702, 9478703, 9478704, 9478705, 9478706, 9478707, 9478708, 9478709, 9482120, 9482121, 9482122, 9482124, 9482125, 9482126, 9482127, 9486300, 9486301, 9486302, 9506575, 9506576, 9506577, 9506578, 9506579, 9506581, 9508748, 9508749, 9508750, 9512178, 9515062, 9515063, 9515132, 9517941, 9517965, 9517966, 9517968, 9517969, 9517970, 9517974, 9561011, 9566155, 9566176, 9566177, 9569135, 9569136, 9572239, 9572240, 9575340, 9581850, 9581851, 9581852, 9584258, 9584260, 9587392, 9587393, 9587394, 9587395, 9587424, 9587425, 9587426, 9587427, 9587428, 9587429, 9587430, 9587431, 9592483, 9594200, 9594220, 9594221, 9598730, 9602931, 9602932, 9605706, 9605707, 9605708, 9605709, 9605710, 9605711, 9609111, 9609112, 9620381, 9620391, 9620392, 9620393, 9620394, 9625904, 9629879, 9633299, 9633302, 9633303, 9633304, 9633305, 9633306, 9633307, 9633308, 9633309, 9633335, 9636344, 9636345, 9636346, 9636347, 9640567, 9640568, 9640569, 9640570, 9640571, 9647075, 9647101, 9647102, 9647103, 9647104, 9647105, 9647106, 9647107, 9647108, 9650089, 9650090, 9653860, 9653884, 9653885, 9653886, 9653887, 9653888, 9653889, 9653890, 9653891, 9276034X, 9370230X 9272844, 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Products Sold
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Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22 due to may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Recommended Action
Per FDA guidance
Urgent Medical Device Recall notification letters dated 4/26/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026