Z-0129-2008

Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator...

Name: Z-0129-2008 Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator...
Creator: Welch Allyn Protocol, Inc
Published: 2007-10-26
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2007-10-26 / Terminated / root cause: manufacturing process

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers... on 2007-10-26. The reason FDA records is "Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0129-2008
Status: Terminated
Initiated: 2007-10-26
Posted: 2007-11-06
Terminated: 2011-11-09
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E;
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued a press release on 10/30/07, and has set up a call center for customers, and plans to send three (3) certified mailings to notify affected customers, alert them of the issue, and provide instructions on how to return their device. The first letter dated 10/26/07 was sent via certified mail to customers on 10/26/07. The letter informs customers of the firm recalling the product to correct faulty capacitors on the circuit board, and which could result in a malfunction that prevents or delays delivery of a defibrillating shock. The letter indicates the faulty AED10 devices were manufactured between 3/29/07 and 8/9/07. The letter also indicates the serial numbers affected, and where the serial number is located - upper left hand corner of the back panel of the device. In addition the letter includes a response form, the firm's contact information, and indicates that the firm will exchange the recalled defibrillator with a replacement and new five (5) year warranty.
Quantity in commerce: 1,794 distributed - 1176 in US and 618 internationally
Distribution: Worldwide.
Product codes and lots: Serial numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005, NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025, NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035, NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052, NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092, NA037093, NA037094, NA037095, NA037097, NA037098, NA037108, NA037110, NA037111, NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121, NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129, NA037132, NA037134, NA037139, NA037140, NA037143, NA037145, NA037146, NA037147, NA037148, NA037149, NA037150, NA037154, NA037155, NA037157, NA037158, NA037159, NA037160, NA037161, NA037162, NA037163, NA037164, NA037166, NA037167, NA037168, NA037169, NA037170, NA037171, NA037172, NA037173, NA037174, NA037175, NA037177, NA037179, NA037180, NA037182, NA037183, NA037184, NA037185, NA037186, NA037187, NA037188, NA037189, NA037190, NA037193, NA037194, NA037203, NA037206, NA037207, NA037209, NA037210, NA037213, NA037217, NA037219, NA037220, NA037221, NA037223, NA037225, NA037228, NA037234, NA037256, NA037354, NA037499, NA037511, NA037512, NA037513, NA037515, NA037516, NA037517, NA037518, NA037519, NA037523, NA037524, NA037525, NA037532, NA037533, NA037534, NA037535, NA037536, NA037538, NA037539, NA037540, NA037541, NA037542, NA037543, NA037544, NA037545, NA037546, NA037547, NA037548, NA037549, NA037550, NA037551, NA037552, NA037553, NA037554, NA037555, NA037556, NA037557, NA037558, NA037559, NA037560, NA037561, NA037562, NA037563, NA037564, NA037565, NA037566, NA037567, NA037568, NA037569, NA037570, NA037571, NA037572, NA037573, NA037574, NA037575, NA037576, NA037577, NA037578, NA037579, NA037580, NA037581, NA037582, NA037583, NA037584, NA037585, NA037586, NA037587, NA037588, NA037589, NA037590, NA037591, NA037592, NA037593, NA037594, NA037595, NA037596, NA037597, NA037598, NA037599, NA037600, NA037601, NA037602, NA037603, NA037604, NA037605, NA037606, NA037607, NA037608, NA037609, NA037610, NA037614, NA037615, NA037616, NA037617, NA037619, NA037620, NA037621, NA037622, NA037624, NA037625, NA037626, NA037627, NA037628, NA037629, NA037630, NA037631, NA037632, NA037633, NA037634, NA037635, NA037636, NA037637, NA037638, NA037639, NA037640, NA037641, NA037643, NA037644, NA037645, NA037646, NA037647, NA037648, NA037649, NA037650, NA037651, NA037652, NA037653, NA037654, NA037655, NA037656, NA037658, NA037659, NA037660, NA037661, NA037662, NA037663, NA037664, NA037665, NA037666, NA037667, NA037668, NA037669, NA037670, NA037671, NA037672, NA037673, NA037674, NA037675, NA037676, NA037677, NA037678, NA037679, NA037680, NA037681, NA037682, NA037683, NA037684, NA037685, NA037686, NA037688, NA037691, NA037696, NA037699, NA037700, NA037702, NA037704, NA037705, NA037706, NA037707, NA037708, NA037712, NA037713, NA037716, NA037717, NA037719, NA037720, NA037723, NA037724, NA037725, NA037729, NA037730, NA037731, NA037732, NA037738, NA037742, NA037743, NA037745, NA037746, NA037747, NA037749, NA037750, NA037751, NA037752, NA037757, NA037761, NA037762, NA037765, NA037766, NA037768, NA037769, NA037770, NA037773, NA037775, NA037779, NA037780, NA037781, NA037782, NA037784, NA037785, NA037786, NA037787, NA037788, NA037789, NA037790, NA037794, NA037795, NA037796, NA037797, NA037798, NA037800, NA037801, NA037802, NA037803, NA037804, NA037805, NA037806, NA037808, NA037809, NA037810, NA037811, NA037814, NA037816, NA037817, NA037818, NA037819, NA037821, NA037822, NA037823, NA037824, NA037825, NA037826, NA037828, NA037829, NA037831, NA037832, NA037834, NA037835, NA037836, NA037837, NA037838, NA037839, NA037840, NA037841, NA037842, NA037843, NA037844, NA037845, NA037846, NA037847, NA037848, NA037849, NA037850, NA037851, NA037852, NA037853, NA037854, NA037855, NA037856, NA037857, NA037858, NA037859, NA037860, NA037861, NA037862, NA037863, NA037864, NA037866, NA037867, NA037869, NA037870, NA037871, NA037872, NA037873, NA037874, NA037875, NA037876, NA037877, NA037878, NA037879, NA037880, NA037881, NA037882, NA037883, NA037884, NA037885, NA037886, NA037887, NA037888, NA037889, NA037890, NA037891, NA037892, NA037893, NA037894, NA037895, NA037896, NA037897, NA037898, NA037899, NA037900, NA037901, NA037902, NA037903, NA037904, NA037905, NA037906, NA037907, NA037908, NA037909, NA037911, NA037912, NA037913, NA037915, NA037918, NA037919, NA037920, NA037922, NA037923, NA037924, NA037926, NA037927, NA037928, NA037929, NA037930, NA037931, NA037932, NA037933, NA037934, NA037935, NA037936, NA037937, NA037939, NA037940, NA037942, NA037943, NA037944, NA037946, NA037947, NA037948, NA037950, NA037952, NA037954, NA037959, NA037960, NA037963, NA037969, NA037971, NA037972, NA037973, NA037975, NA037977, NA037978, NA037979, NA037980, NA038000, NA038004, NA038005, NA038012, NA038027, NA038028, NA038029, NA038030, NA038031, NA038032, NA038033, NA038035, NA038036, NA038037, NA038038, NA038039, NA038040, NA038041, NA038042, NA038043, NA038044, NA038045, NA038046, NA038047, NA038048, NA038049, NA038050, NA038051, NA038052, NA038053, NA038054, NA038056, NA038057, NA038058, NA038059, NA038060, NA038061, NA038062, NA038063, NA038064, NA038065, NA038066, NA038067, NA038068, NA038069, NA038070, NA038072, NA038073, NA038074, NA038075, NA038076, NA038077, NA038078, NA038080, NA038081, NA038082, NA038083, NA038084, NA038085, NA038086, NA038087, NA038088, NA038089, NA038090, NA038091, NA038092, NA038093, NA038094, NA038095, NA038096, NA038097, NA038098, NA038099, NA038100, NA038101, NA038102, NA038103, NA038104, NA038105, NA038106, NA038107, NA038108, NA038109, NA038110, NA038111, NA038112, NA038113, NA038114, NA038116, NA038117, NA038118, NA038119, NA038120, NA038121, NA038122, NA038123, NA038124, NA038125, NA038126, NA038127, NA038128, NA038129, NA038130, NA038131, NA038132, NA038133, NA038134, NA038135, NA038136, NA038137, NA038138, NA038139, NA038140, NA038141, NA038142, NA038143, NA038144, NA038145, NA038146, NA038147, NA038148, NA038149, NA038150, NA038151, NA038152, NA038153, NA038154, NA038155, NA038156, NA038157, NA038158, NA038159, NA038160, NA038161, NA038162, NA038163, NA038164, NA038165, NA038166, NA038167, NA038168, NA038169, NA038170, NA038171, NA038172, NA038174, NA038175, NA038176, NA038177, NA038178, NA038179, NA038180, NA038181, NA038182, NA038183, NA038184, NA038185, NA038186, NA038187, NA038188, NA038189, NA038190, NA038191, NA038193, NA038194, NA038195, NA038196, NA038197, NA038198, NA038199, NA038200, NA038201, NA038202, NA038203, NA038204, NA038205, NA038206, NA038207, NA038208, NA038209, NA038210, NA038211, NA038213, NA038214, NA038215, NA038216, NA038217, NA038218, NA038219, NA038220, NA038221, NA038222, NA038223, NA038224, NA038225, NA038226, NA038227, NA038228, NA038229, NA038230, NA038231, NA038232, NA038233, NA038234, NA038235, NA038236, NA038237, NA038238, NA038239, NA038240, NA038241, NA038242, NA038243, NA038244, NA038245, NA038246, NA038247, NA038249, NA038250, NA038251, NA038252, NA038253, NA038254, NA038255, NA038256, NA038257, NA038258, NA038259, NA038260, NA038261, NA038262, NA038263, NA038264, NA038265, NA038266, NA038267, NA038268, NA038269, NA038270, NA038271, NA038272, NA038273, NA038274, NA038275, NA038276, NA038277, NA038278, NA038279, NA038280, NA038281, NA038282, NA038283, NA038284, NA038285, NA038286, NA038287, NA038288, NA038289, NA038290, NA038291, NA038292, NA038293, NA038294, NA038295, NA038296, NA038297, NA038298, NA038299, NA038300, NA038301, NA038302, NA038303, NA038304, NA038305, NA038306, NA038307, NA038308, NA038309, NA038310, NA038311, NA038312, NA038313, NA038314, NA038315, NA038316, NA038317, NA038318, NA038319, NA038320, NA038321, NA038322, NA038323, NA038324, NA038325, NA038326, NA038327, NA038328, NA038329, NA038330, NA038331, NA038332, NA038333, NA038334, NA038335, NA038336, NA038337, NA038338, NA038339, NA038340, NA038341, NA038342, NA038343, NA038344, NA038345, NA038346, NA038347, NA038348, NA038349, NA038350, NA038351, NA038352, NA038353, NA038354, NA038355, NA038356, NA038357, NA038358, NA038359, NA038360, NA038361, NA038362, NA038363, NA038364, NA038365, NA038366, NA038367, NA038368, NA038369, NA038370, NA038371, NA038372, NA038373, NA038374, NA038375, NA038376, NA038377, NA038378, NA038379, NA038380, NA038381, NA038382, NA038383, NA038384, NA038385, NA038388, NA038389, NA038390, NA038392, NA038393, NA038396, NA038397, NA038398, NA038399, NA038400, NA038403, NA038404, NA038406, NA038407, NA038409, NA038410, NA038412, NA038413, NA038414, NA038415, NA038416, NA038417, NA038420, NA038421, NA038422, NA038423, NA038425, NA038427, NA038428, NA038429, NA038430, NA038432, NA038434, NA038435, NA038436, NA038437, NA038438, NA038439, NA038440, NA038441, NA038442, NA038443, NA038447, NA038448, NA038449, NA038450, NA038452, NA038453, NA038454, NA038455, NA038456, NA038457, NA038458, NA038459, NA038465, NA038467, NA038468, NA038471, NA038472, NA038473, NA038475, NA038476, NA038477, NA038478, NA038479, NA038483, NA038484, NA038485, NA038486, NA038489, NA038490, NA038492, NA038493, NA038494, NA038496, NA038498, NA038499, NA038500, NA038501, NA038502, NA038503, NA038504, NA038505, NA038506, NA038507, NA038508, NA038509, NA038510, NA038511, NA038512, NA038513, NA038514, NA038515, NA038516, NA038517, NA038518, NA038519, NA038520, NA038521, NA038522, NA038523, NA038524, NA038526, NA038527, NA038528, NA038529, NA038531, NA038532, NA038533, NA038536, NA038538, NA038539, NA038541, NA038542, NA038543, NA038544, NA038545, NA038547, NA038549, NA038550, NA038551, NA038552, NA038554, NA038555, NA038556, NA038557, NA038558, NA038559, NA038560, NA038561, NA038562, NA038564, NA038565, NA038566, NA038567, NA038568, NA038569, NA038570, NA038571, NA038572, NA038573, NA038574, NA038575, NA038576, NA038577, NA038578, NA038579, NA038580, NA038581, NA038582, NA038583, NA038585, NA038586, NA038587, NA038589, NA038590, NA038591, NA038592, NA038593, NA038594, NA038595, NA038596, NA038597, NA038598, NA038599, NA038600, NA038601, NA038602, NA038603, NA038604, NA038605, NA038607, NA038608, NA038609, NA038610, NA038612, NA038613, NA038614, NA038616, NA038618, NA038619, NA038624, NA038625, NA038626, NA038627, NA038628, NA038629, NA038630, NA038632, NA038634, NA038635, NA038636, NA038637, NA038638, NA038639, NA038640, NA038641, NA038642, NA038643, NA038644, NA038645, NA038646, NA038648, NA038649, NA038650, NA038651, NA038652, NA038653, NA038654, NA038658, NA038659, NA038662, NA038665, NA038666, NA038667, NA038668, NA038669, NA038671, NA038672, NA038673, NA038674, NA038675, NA038676, NA038677, NA038678, NA038679, NA038680, NA038683, NA038684, NA038685, NA038686, NA038687, NA038688, NA038690, NA038691, NA038692, NA038693, NA038694, NA038696, NA038697, NA038699, NA038700, NA038702, NA038704, NA038705, NA038706, NA038707, NA038709, NA038711, NA038712, NA038713, NA038714, NA038715, NA038716, NA038717, NA038718, NA038719, NA038720, NA038721, NA038722, NA038723, NA038725, NA038726, NA038727, NA038728, NA038729, NA038730, NA038731, NA038732, NA038733, NA038734, NA038735, NA038736, NA038737, NA038738, NA038739, NA038740, NA038741, NA038742, NA038743, NA038744, NA038745, NA038746, NA038747, NA038748, NA038749, NA038750, NA038751, NA038752, NA038753, NA038754, NA038755, NA038756, NA038757, NA038758, NA038759, NA038760, NA038761, NA038762, NA038763, NA038764, NA038765, NA038766, NA038767, NA038768, NA038769, NA038770, NA038771, NA038772, NA038773, NA038774, NA038775, NA038776, NA038777, NA038778, NA038779, NA038780, NA038781, NA038782, NA038783, NA038784, NA038785, NA038786, NA038787, NA038788, NA038789, NA038791, NA038792, NA038793, NA038794, NA038795, NA038796, NA038797, NA038798, NA038799, NA038800, NA038801, NA038802, NA038803, NA038804, NA038805, NA038806, NA038807, NA038808, NA038809, NA038810, NA038811, NA038814, NA038815, NA038816, NA038817, NA038818, NA038819, NA038820, NA038821, NA038822, NA038823, NA038824, NA038825, NA038826, NA038827, NA038828, NA038829, NA038831, NA038832, NA038833, NA038834, NA038835, NA038836, NA038837, NA038838, NA038839, NA038840, NA038841, NA038842, NA038843, NA038845, NA038846, NA038847, NA038848, NA038849, NA038850, NA038851, NA038852, NA038853, NA038854, NA038855, NA038856, NA038857, NA038858, NA038859, NA038860, NA038861, NA038862, NA038863, NA038864, NA038865, NA038867, NA038868, NA038869, NA038870, NA038871, NA038872, NA038873, NA038874, NA038875, NA038876, NA038877, NA038878, NA038879, NA038880, NA038881, NA038882, NA038883, NA038884, NA038885, NA038886, NA038887, NA038888, NA038889, NA038890, NA038892, NA038894, NA038896, NA038897, NA038898, NA038899, NA038900, NA038901, NA038902, NA038903, NA038904, NA038905, NA038906, NA038907, NA038908, NA038909, NA038911, NA038912, NA038913, NA038914, NA038915, NA038916, NA038917, NA038918, NA038919, NA038920, NA038921, NA038922, NA038923, NA038924, NA038925, NA038926, NA038927, NA038928, NA038929, NA038930, NA038931, NA038932, NA038933, NA038934, NA038935, NA038936, NA038937, NA038938, NA038939, NA038940, NA038942, NA038943, NA038944, NA038945, NA038946, NA038947, NA038951, NA038952, NA038953, NA038956, NA038957, NA038958, NA038959, NA038960, NA038961, NA038963, NA038964, NA038965, NA038966, NA038969, NA038970, NA038971, NA038973, NA038975, NA038979, NA038980, NA038981, NA038982, NA038983, NA038985, NA038986, NA038988, NA038989, NA038991, NA038993, NA038994, NA038995, NA038996, NA038997, NA039004, NA039005, NA039006, NA039007, NA039008, NA039009, NA039010, NA039011, NA039012, NA039014, NA039015, NA039016, NA039017, NA039018, NA039019, NA039020, NA039021, NA039022, NA039025, NA039026, NA039027, NA039028, NA039029, NA039030, NA039031, NA039032, NA039033, NA039034, NA039035, NA039036, NA039037, NA039038, NA039039, NA039040, NA039041, NA039042, NA039047, NA039048, NA039049, NA039050, NA039051, NA039052, NA039053, NA039054, NA039055, NA039056, NA039057, NA039058, NA039059, NA039060, NA039061, NA039062, NA039063, NA039064, NA039065, NA039066, NA039067, NA039068, NA039069, NA039070, NA039071, NA039072, NA039073, NA039074, NA039075, NA039076, NA039077, NA039078, NA039079, NA039080, NA039081, NA039083, NA039084, NA039085, NA039086, NA039087, NA039088, NA039089, NA039090, NA039091, NA039092, NA039093, NA039094, NA039095, NA039096, NA039097, NA039098, NA039099, NA039100, NA039101, NA039102, NA039103, NA039104, NA039105, NA039106, NA039107, NA039108, NA039109, NA039110, NA039111, NA039112, NA039113, NA039114, NA039115, NA039116, NA039117, NA039118, NA039119, NA039120, NA039121, NA039122, NA039123, NA039124, NA039125, NA039126, NA039127, NA039128, NA039129, NA039130, NA039131, NA039132, NA039133, NA039134, NA039135, NA039136, NA039137, NA039138, NA039139, NA039140, NA039141, NA039142, NA039143, NA039144, NA039145, NA039146, NA039147, NA039148, NA039149, NA039150, NA039151, NA039152, NA039153, NA039154, NA039155, NA039156, NA039157, NA039158, NA039159, NA039160, NA039161, NA039162, NA039163, NA039164, NA039165, NA039166, NA039167, NA039168, NA039169, NA039170, NA039171, NA039172, NA039173, NA039174, NA039175, NA039176, NA039177, NA039178, NA039179, NA039180, NA039181, NA039182, NA039183, NA039184, NA039185, NA039186, NA039187, NA039188, NA039189, NA039190, NA039191, NA039192, NA039193, NA039194, NA039195, NA039196, NA039197, NA039198, NA039200, NA039201, NA039202, NA039203, NA039204, NA039205, NA039206, NA039207, NA039208, NA039209, NA039210, NA039211, NA039212, NA039213, NA039214, NA039215, NA039216, NA039217, NA039218, NA039219, NA039220, NA039221, NA039222, NA039223, NA039224, NA039225, NA039226, NA039227, NA039228, NA039229, NA039230, NA039231, NA039232, NA039233, NA039234, NA039235, NA039236, NA039237, NA039238, NA039239, NA039240, NA039241, NA039242, NA039243, NA039244, NA039245, NA039246, NA039247, NA039248, NA039249, NA039250, NA039251, NA039252, NA039253, NA039254, NA039255, NA039256, NA039257, NA039258, NA039259, NA039260, NA039261, NA039262, NA039263, NA039264, NA039265, NA039266, NA039267, NA039268, NA039269, NA039270, NA039271, NA039272, NA039273, NA039274, NA039275, NA039276, NA039277, NA039278, NA039279, NA039280, NA039281, NA039282, NA039283, NA039284, NA039285, NA039286, NA039287, NA039288, NA039289, NA039290, NA039291, NA039292, NA039293, NA039294, NA039295, NA039296, NA039297, NA039298, NA039299, NA039300, NA039301, NA039302, NA039303, NA039304, NA039305, NA039306, NA039307, NA039308, NA039309, NA039310, NA039311, NA039312, NA039313, NA039314, NA039315, NA039316, NA039317, NA039318, NA039319, NA039320, NA039321, NA039322, NA039324, NA039327, NA039328, NA039329, NA039330, NA039331, NA039332, NA039334, NA039335, NA039336, NA039337, NA039340, NA039341, NA039342, NA039343, NA039344, NA039345, NA039346, NA039347, NA039349, NA039350, NA039351, NA039352, NA039353, NA039354, NA039355, NA039356, NA039357, NA039358, NA039359, NA039360, NA039361, NA039362, NA039363, NA039364, NA039366, NA039367, NA039368, NA039369, NA039370, NA039371, NA039372, NA039373, NA039374, NA039375, NA039376, NA039377, NA039378, NA039379, NA039380, NA039381, NA039382, NA039383, NA039385, NA039386, NA039387, NA039388, NA039389, NA039390, NA039391, NA039392, NA039393, NA039394, NA039395, NA039396, NA039397, NA039398, NA039399, NA039400, NA039401, NA039402, NA039403, NA039404, NA039405, NA039406, NA039407, NA039408, NA039409, NA039410, NA039411, NA039412, NA039413, NA039414, NA039415, NA039416, NA039417, NA039418, NA039419, NA039420, NA039421, NA039422, NA039423, NA039424, NA039425, NA039426, NA039427, NA039428, NA039429, NA039430, NA039431, NA039432, NA039433, NA039434, NA039435, NA039436, NA039437, NA039438, NA039439, NA039440, NA039441, NA039442, NA039443, NA039444, NA039445, NA039446, NA039447, NA039448, NA039449, NA039450, NA039451, NA039452, NA039453, NA039454, NA039455, NA039456, NA039457, NA039458, NA039459, NA039460, NA039461, NA039462, NA039463, NA039464, NA039465, NA039466, NA039467, NA039468, NA039469, NA039470, NA039471, NA039472, NA039473, NA039474, NA039475, NA039476, NA039477, NA039478, NA039479, NA039480, NA039481, NA039482, NA039483, NA039484, NA039485, NA039486, NA039487, NA039488, NA039489, NA039490, NA039491, NA039492, NA039493, NA039494, NA039495, NA039497, NA039498, NA039499, NA039500, NA039501, NA039502, NA039503, NA039504, NA039505, NA039506, NA039507, NA039508, NA039510, NA039511, NA039512, NA039514, NA039515, NA039516, NA039517, NA039518, NA039519, NA039520, NA039521, NA039522, NA039523, NA039524, NA039525, NA039526, NA039527, NA039528, NA039529, NA039530, NA039531, NA039532, NA039533, NA039534, NA039535, NA039536, NA039537, NA039538, NA039539, NA039540, NA039541, NA039542, NA039543, NA039544, NA039545, NA039546, NA039547, NA039548, NA039549, NA039550, NA039551, NA039552, NA039553, NA039554, NA039555, NA039556, NA039558, NA039560, NA039561, NA039562, NA039563, NA039564, NA039565, NA039566, NA039567, NA039568, NA039569, NA039570, NA039571, NA039572, NA039573, NA039574, NA039575, NA039577, NA039578, NA039579, NA039581, NA039582, NA039584, NA039585, NA039586, NA039588, NA039589, NA039591, NA039592, NA039593, NA039595, NA039598, NA039599, NA039600, NA039601, NA039603, NA039604, NA039605, NA039607, NA039608, NA039609, NA039612, NA039616, NA039618, NA039619, NA039620, NA039621, NA039623, NA039624, NA039629, NA039630, NA039632, NA039633, NA039639, NA039644, NA039645, NA039650, NA039655, NA039664, NA039674, NA039692, NA039701, NA039702, NA039703, NA039711, NA039715, NA039719, NA039720, NA039722, NA039723, NA039724, NA039726, NA039728, NA039729, NA039730, NA039732, NA039733, NA039734, NA039735, NA039736, NA039737, NA039741, NA039742, NA039743, NA039744, NA039747, NA039748, NA039750, NA039751, NA039753, NA039754, NA039755, NA039756, NA039757, NA039758, NA039759, NA039760, NA039761, NA039762, NA039763, NA039764, NA039766, NA039767, NA039771, NA039772, NA039773, NA039774, NA039776, NA039778, NA039780, NA039781, NA039782, NA039784, NA039785, NA039786, NA039787, NA039790, NA039793, NA039795, NA039796, NA039797, NA039798, NA039799, NA039800, NA039802, NA039803, NA039804, NA039805, NA039806, NA039808, NA039809, NA039810, NA039814, NA039828, NA039839, NA039842, NA039843, NA039844, NA039846, NA039847, NA039848, NA039849, NA039850, NA039851, NA039852, NA039853, NA039854, NA039855, NA039856, NA039857, NA039858, NA039859, NA039860, NA039865, NA039866, NA039868, NA039871, NA039876, NA039877, NA039878

Product code MKJ

K021168Class IIIJump Start, Model 970300Medical Research Laboratories, Inc. / cleared 2002-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)