CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

BladderScan BVI recalled by Verathon

Verathon is recalling BladderScan BVI 9600, distributed nationwide in the US. The recall was initiated on 30 Nov 2015 and the FDA has classified it as Class II.

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Lot, batch or date codesSERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, 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B6001831, B6001832, B6001833, B6001834, B6001835, B6001836, B6001838, B6001839, B6001840, B6001841, B6001842, B6001843, B6001844, B6001845, B6001846, B6001848, B6001849, B6001850, B6001851, B6001852, B6001853, B6001854, B6001855, B6001856, B6001857, B6001858, B6001859, B6001860, B6001861, B6001862, B6001863, B6001864, B6001865, B6001866, B6001867, B6001868, B6001869, B6001870, B6001871, B6001872, B6001873, B6001874, B6001875, B6001876, B6001877, B6001878, B6001879, B6001880, B6001881, B6001882, B6001883, B6001884, B6001885, B6001887, B6001888, B6001889, B6001890, B6001891, B6001892, B6001893, B6001894, B6001895, B6001896, B6001897, B6001898, B6001899, B6001900, B6001901, B6001902, B6001903, B6001904, B6001905, B6001906, B6001907, B6001908, B6001909, B6001910, B6001911, B6001912, B6001913, B6001914, B6001915, B6001916, B6001917, B6001918, B6001919, B6001920, B6001921, B6001922, B6001923, B6001924, B6001925, B6001926, B6001927, B6001928, B6001930, B6001931, B6001932, B6001934, B6001935, B6001936, B6001937, B6001938, B6001939, B6001940, B6001941, B6001942, B6001943, B6001944, B6001945, B6001946, B6001947, B6001948, B6001949, B6001950, B6001951, B6001952, B6001953, B6001954, B6001955, B6001956, B6001957, B6001958, B6001959, B6001960, B6001961, B6001962, B6001963, B6001964, B6001965, B6001966, B6001967, B6001968, B6001969, B6001972, B6001973, B6001974, B6001975, B6001976, B6001977, B6001978, B6001979, B6001980, B6001981, B6001982, B6001983, B6001984, B6001986, B6001987, B6001988, B6001989, B6001990, B6001991, B6001992, B6001993, B6001994, B6001995, B6001996, B6001997, B6001998, B6001999, B6002000, B6002001, B6002002, B6002003, B6002004, B6002005, B6002007, B6002008, B6002009, B6002010, B6002011, B6002012, B6002013, B6002014, B6002015, B6002016, B6002017, B6002018, B6002019, B6002020, B6002021, B6002022, B6002023, B6002024, B6002025, B6002026, B6002027, B6002028, B6002029, B6002030, B6002031, B6002032, B6002033, B6002034, B6002035, B6002036, B6002037, B6002038, B6002039, B6002040, B6002041, B6002042, B6002043, B6002044, B6002045, B6002047, B6002048, B6002049, B6002050, B6002051, B6002052, B6002054, B6002055, B6002057, B6002058, B6002059, B6002060, B6002061, B6002062, B6002063, B6002064, B6002065, B6002066, B6002067, B6002068, B6002069, B6002070, B6002071, B6002072, B6002073, B6002074, B6002075, B6002076, B6002077, B6002078, B6002079, B6002080, B6002081, B6002082, B6002083, B6002084, B6002085, B6002086, B6002087, B6002088, B6002089, B6002090, B6002091, B6002092, B6002093, B6002094, B6002096, B6002097, B6002098, B6002099, B6002100, B6002101, B6002102, B6002103, B6002104, B6002105, B6002106, B6002107, B6002108, B6002109, B6002110, B6002111, B6002112, B6002113, B6002114, B6002115, B6002116, B6002117, B6002118, B6002119, B6002120, B6002121, B6002122, B6002123, B6002124, B6002125, B6002126, B6002127, B6002128, B6002129, B6002130, B6002131, B6002132, B6002133, B6002134, B6002135, B6002136, B6002137, B6002138, B6002139, B6002140, B6002141, B6002142, B6002143, B6002145, B6002147, B6002148, B6002149, B6002150, B6002151, B6002152, B6002153, B6002154, B6002155, B6002156, B6002157, B6002158, B6002159, B6002160, B6002161, B6002162, B6002163, B6002164, B6002168, B6002169, B6002170, B6002171, B6002172, B6002173, B6002174, B6002175, B6002176, B6002177, B6002178, B6002179, B6002180, B6002181, B6002182, B6002183, B6002184, B6002185, B6002186, B6002187, B6002188, B6002189, B6002190, B6002191, B6002192, B6002193, B6002195, B6002196, B6002197, B6002198, B6002199, B6002200, B6002201, B6002202, B6002203, B6002204, B6002205, B6002206, B6002207, B6002208, B6002209, B6002210, B6002211, B6002212, B6002213, B6002214, B6002215, B6002216, B6002217, B6002218, B6002219, B6002220, B6002221, B6002222, B6002223, B6002224, B6002225, B6002226, B6002227, B6002228, B6002229, B6002230, B6002231, B6002232, B6002233, B6002234, B6002235, B6002236, B6002237, B6002238, B6002239, B6002240, B6002241, B6002242, B6002243, B6002244, B6002245, B6002246, B6002247, B6002248, B6002251, B6002252, B6002253, B6002254, B6002255, B6002256, B6002257, B6002258, B6002259, B6002260, B6002261, B6002262, B6002263, B6002264, B6002265, B6002266, B6002267, B6002268, B6002269, B6002270, B6002271, B6002272, B6002273, B6002274, B6002275, B6002276, B6002277, B6002278, B6002279, B6002280, B6002281, B6002282, B6002283, B6002284, B6002285, B6002286, B6002287, B6002288, B6002289, B6002292, B6002293, B6002294, B6002295, B6002296, B6002297, B6002298, B6002299, B6002300, B6002301, B6002302, B6002303, B6002304, B6002305, B6002306, B6002307, B6002308, B6002309, B6002310, B6002311, B6002313, B6002314, B6002315, B6002316, B6002317, B6002318, B6002319, B6002320, B6002321, B6002322, B6002323, B6002324, B6002325, B6002326, B6002327, B6002328, B6002329, B6002331, B6002332, B6002334, B6002335, B6002336, B6002337, B6002338, B6002339, B6002340, B6002341, B6002342, B6002343, B6002345, B6002346, B6002347, B6002348, B6002349, B6002350, B6002351, B6002352, B6002353, B6002354, B6002356, B6002357, B6002358, B6002359, B6002360, B6002361, B6002362, B6002363, B6002364, B6002365, B6002366, B6002367, B6002368, B6002369, B6002370, B6002371, B6002373, B6002374, B6002375, B6002376, B6002377, B6002378, B6002379, B6002381, B6002382, B6002383, B6002384, B6002385, B6002386, B6002387, B6002388, B6002389, B6002390, B6002391, B6002392, B6002393, B6002394, B6002395, B6002396, B6002398, B6002399, B6002401, B6002402, B6002403, B6002404, B6002405, B6002406, B6002407, B6002408, B6002411, B6002412, B6002413, B6002414, B6002415, B6002416, B6002417, B6002418, B6002419, B6002420, B6002421, B6002422, B6002423, B6002424, B6002425, B6002426, B6002427, B6002428, B6002429, B6002430, B6002431, B6002432, B6002433, B6002434, B6002435, B6002436, B6002437, B6002438, B6002439, B6002440, B6002441, B6002442, B6002443, B6002444, B6002445, B6002446, B6002447, B6002448, B6002449, B6002451, B6002452, B6002457, B6002458, B6002459, B6002460, B6002461, B6002462, B6002463, B6002469, B6002470, B6002471, B6002472, B6002473, B6002474, B6002475, B6002476, B6002477, B6002478, B6002479, B6002480, B6002481, B6002482, B6002483, B6002484, B6002485, B6002486, B6002487, B6002488, B6002489, B6002490, B6002491, B6002492, B6002493, B6002494, B6002495, B6002496, B6002504, B6002505, B6002506, B6002507, B6002508, B6002509, B6002510, B6002511, B6002512, B6002513, B6002514, B6002515, B6002519, B6002520, B6002521, B6002522, B6002524, B6002525, B6002526, B6002528, B6002529, B6002530, B6002531, B6002534, B6002535, B6002536, B6002542, B6002543, B6002544, B6002545, B6002546, B6002547, B6002548, B6002549, B6002550, B6002551, B6002553, B6002554, B6002555, B6002556, B6002557, B6002558, B6002559, B6002560, B6002561, B6002562, B6002563, B6002564, B6002565, B6002566, B6002602, B6002667, B6002668, B6002669, B6002670, B6002671, B6002672, B6002673, B6002674, B6002675, B6002676, B6002677, B6002678, B6002679, B6002680, B6002681, B6002682, B6002683, B6002684, B6002685, B6002686, B6002687, B6002688, B6002689, B6002690, B6002691, B6002692, B6002693, B6002694, B6002695, B6002696, B6002697, B6002698, B6002700, B6002701, B6002702, B6002703, B6002704, B6002705, B6002707, B6002708, B6002709, B6002710, B6002711, B6002712, B6002713, B6002714, B6002715, B6002716, B6002717, B6002718, B6002719, B6002720, B6002722, B6002723, B6002724, B6002725, B6002726, B6002727, B6002728, B6002729, B6002730, B6002732, B6002733, B6002734, B6002735, B6002736, B6002737, B6002746, B6002747, B6002748, B6002749, B6002750, B6002751, B6002752, B6002753, B6002754, B6002755, B6002756, B6002757, B6002758, B6002759, B6002760, B6002761, B6002762, B6002763, B6002764, B6002765, B6002766, B6002767, B6002768, B6002769, B6002770, B6002771, B6002772, B6002773, B6002774, B6002775, B6002777, B6002778, B6002779, B6002781, B6002782, B6002783, B6002784, B6002785, B6002786, B6002787, B6002788, B6002789, B6002790, B6002791, B6002792, B6002793, B6002794, B6002795, B6002796, B6002797, B6002798, B6002799, B6002800, B6002801, B6002803, B6002805, B6002806, B6002807, B6002808, B6002809, B6002810, B6002811, B6002812, B6002813, B6002815, B6002816, B6002817, B6002818, B6002819, B6002820, B6002821, B6002822, B6002823, B6002824, B6002825, B6002826, B6002827, B6002828, B6002829, B6002830, B6002831, B6002832, B6002833, B6002834, B6002835, B6002836, B6002837, B6002838, B6002839, B6002840, B6002841, B6002842, B6002843, B6002844, B6002845, B6002849, B6002857, B6002858, B6002859, B6002860, B6002861, B6002862, B6002863, B6002864, B6002865, B6002866, B6002867, B6002868, B6002869, B6002870, B6002871, B6002872, B6002873, B6002874, B6002875, B6002876, B6002878, B6002879, B6002880, B6002881, B6002882, B6002883, B6002884, B6002885, B6002886, B6002888, B6002889, B6002890, B6002891, and B6002892. ****SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA***** 00001001, 00001007, 00001008, A7001048, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001095, A7001096, A7001097, A7001100, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001133, A7001136, A7001263, A7001280, A7001282, A7001442, A7001443, A7001444, A7001720, A7001796, A7001797, A7001798, A7001799, A7001829, A7001830, A7001831, A7001832, A7001833, A7001834, A7001835, A7001838, A7001839, A7001840, A7001849, A7001850, A7001851, A7001852, A7001853, A7001854, A7001855, A7001856, B6001063, B6001064, B6001075, B6001079, B6001081, B6001188, B6001189, B6001211, B6001224, B6001233, B6001251, B6001289, B6001294, B6001296, B6001300, B6001337, B6001347, B6001353, B6001368, B6001371, B6001380, B6001383, B6001391, B6001393, B6001394, B6001395, B6001405, B6001412, B6001413, B6001416, B6001418, B6001432, B6001446, B6001447, B6001454, B6001465, B6001466, B6001475, B6001476, B6001517, B6001534, B6001539, B6001540, B6001548, B6001551, B6001552, B6001556, B6001607, B6001625, B6001671, B6001684, B6001690, B6001714, B6001732, B6001745, B6001749, B6001760, B6001763, B6001775, B6001784, B6001785, B6001786, B6001789, B6001792, B6001802, B6001847, B6001886, B6001929, B6001933, B6001970, B6001971, B6001985, B6002053, B6002056, B6002166, B6002167, B6002194, B6002250, B6002290, B6002291, B6002330, B6002333, B6002344, B6002372, B6002409, B6002410, B6002450, B6002453, B6002454, B6002455, B6002456, B6002523, B6002532, B6002533, B6002552, B6002567, B6002568, B6002569, B6002570, B6002571, B6002572, B6002573, B6002574, B6002575, B6002576, B6002577, B6002578, B6002579, B6002580, B6002581, B6002582, B6002583, B6002584, B6002585, B6002586, B6002587, B6002588, B6002589, B6002590, B6002591, B6002592, B6002593, B6002594, B6002595, B6002596, B6002597, B6002598, B6002599, B6002600, B6002601, B6002603, B6002604, B6002605, B6002606, B6002607, B6002608, B6002609, B6002610, B6002611, B6002612, B6002613, B6002614, B6002615, B6002616, B6002617, B6002618, B6002619, B6002620, B6002621, B6002622, B6002623, B6002624, B6002625, B6002626, B6002627, B6002628, B6002629, B6002630, B6002631, B6002632, B6002633, B6002634, B6002635, B6002636, B6002637, B6002638, B6002639, B6002640, B6002641, B6002642, B6002643, B6002644, B6002645, B6002646, B6002647, B6002648, B6002649, B6002650, B6002651, B6002652, B6002653, B6002654, B6002655, B6002656, B6002657, B6002658, B6002659, B6002660, B6002661, B6002662, B6002663, B6002664, B6002665, B6002666, B6002706, B6002731, B6002738, B6002739, B6002740, B6002741, B6002742, B6002743, B6002744, B6002802, B6002804, and B6002877.

Quantity recalled2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1091-2016
FDA event ID: 72486
Recalling firm: Verathon, Bothell, WA
Classification: Class II
Status: Terminated
Recall initiated: 30 Nov 2015
FDA classified: 10 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Nov 2015	Recall initiated by company
10 Mar 2016	Classified by FDA	+101 days
16 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).

Product as listed by the FDA

BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

Where it was distributed

Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom

Nationwide

Questions about this recall

Is BladderScan BVI 9600 recalled?

Yes. Verathon recalled BladderScan BVI 9600 on 30 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-1091-2016.

Why was it recalled?

Which lots are affected?

SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A7001182, A7001183, A7001184, A7001185, A7001186, A7001187, A7001188, A7001189, A7001190, A7001191, A7001192, A7001194, A7001195, A7001196, A7001197, A7001198, A7001199, A7001201, A7001202, A7001204, A7001205, A7001206, A7001207, A7001209, A7001210, A7001211, A7001212, A7001216, A7001217, A7001218, A7001219, A7001220, A7001221, A7001222, A7001223, A7001224, A7001226, A7001227, A7001228, A7001229, A7001231, A7001232, A7001233, A7001234, A7001235, A7001236, A7001237, A7001238, A7001239, A7001240, A7001241, A7001242, A7001243, A7001244, A7001246, A7001247, A7001248, A7001249, A7001250, A7001251, A7001252, A7001253, A7001254, A7001255, A7001256, A7001257, A7001258, A7001260, A7001261, A7001262, A7001264, A7001265, A7001266, A7001268, A7001269, A7001270, A7001271, A7001272, A7001273, A7001275, A7001276, A7001277, A7001278, A7001279, A7001281, A7001283, A7001284, A7001285, A7001286, A7001287, A7001288, A7001289, A7001290, A7001291, A7001292, A7001293, A7001294, A7001295, A7001296, A7001297, 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B6002254, B6002255, B6002256, B6002257, B6002258, B6002259, B6002260, B6002261, B6002262, B6002263, B6002264, B6002265, B6002266, B6002267, B6002268, B6002269, B6002270, B6002271, B6002272, B6002273, B6002274, B6002275, B6002276, B6002277, B6002278, B6002279, B6002280, B6002281, B6002282, B6002283, B6002284, B6002285, B6002286, B6002287, B6002288, B6002289, B6002292, B6002293, B6002294, B6002295, B6002296, B6002297, B6002298, B6002299, B6002300, B6002301, B6002302, B6002303, B6002304, B6002305, B6002306, B6002307, B6002308, B6002309, B6002310, B6002311, B6002313, B6002314, B6002315, B6002316, B6002317, B6002318, B6002319, B6002320, B6002321, B6002322, B6002323, B6002324, B6002325, B6002326, B6002327, B6002328, B6002329, B6002331, B6002332, B6002334, B6002335, B6002336, B6002337, B6002338, B6002339, B6002340, B6002341, B6002342, B6002343, B6002345, B6002346, B6002347, B6002348, B6002349, B6002350, B6002351, B6002352, B6002353, B6002354, B6002356, B6002357, B6002358, B6002359, B6002360, B6002361, B6002362, B6002363, B6002364, B6002365, B6002366, B6002367, B6002368, B6002369, B6002370, B6002371, B6002373, B6002374, B6002375, B6002376, B6002377, B6002378, B6002379, B6002381, B6002382, B6002383, B6002384, B6002385, B6002386, B6002387, B6002388, B6002389, B6002390, B6002391, B6002392, B6002393, B6002394, B6002395, B6002396, B6002398, B6002399, B6002401, B6002402, B6002403, B6002404, B6002405, B6002406, B6002407, B6002408, B6002411, B6002412, B6002413, B6002414, B6002415, B6002416, B6002417, B6002418, B6002419, B6002420, B6002421, B6002422, B6002423, B6002424, B6002425, B6002426, B6002427, B6002428, B6002429, B6002430, B6002431, B6002432, B6002433, B6002434, B6002435, B6002436, B6002437, B6002438, B6002439, B6002440, B6002441, B6002442, B6002443, B6002444, B6002445, B6002446, B6002447, B6002448, B6002449, B6002451, B6002452, B6002457, B6002458, B6002459, B6002460, B6002461, B6002462, B6002463, B6002469, B6002470, B6002471, B6002472, B6002473, B6002474, B6002475, B6002476, B6002477, B6002478, B6002479, B6002480, B6002481, B6002482, B6002483, B6002484, B6002485, B6002486, B6002487, B6002488, B6002489, B6002490, B6002491, B6002492, B6002493, B6002494, B6002495, B6002496, B6002504, B6002505, B6002506, B6002507, B6002508, B6002509, B6002510, B6002511, B6002512, B6002513, B6002514, B6002515, B6002519, B6002520, B6002521, B6002522, B6002524, B6002525, B6002526, B6002528, B6002529, B6002530, B6002531, B6002534, B6002535, B6002536, B6002542, B6002543, B6002544, B6002545, B6002546, B6002547, B6002548, B6002549, B6002550, B6002551, B6002553, B6002554, B6002555, B6002556, B6002557, B6002558, B6002559, B6002560, B6002561, B6002562, B6002563, B6002564, B6002565, B6002566, B6002602, B6002667, B6002668, B6002669, B6002670, B6002671, B6002672, B6002673, B6002674, B6002675, B6002676, B6002677, B6002678, B6002679, B6002680, B6002681, B6002682, B6002683, B6002684, B6002685, B6002686, B6002687, B6002688, B6002689, B6002690, B6002691, B6002692, B6002693, B6002694, B6002695, B6002696, B6002697, B6002698, B6002700, B6002701, B6002702, B6002703, B6002704, B6002705, B6002707, B6002708, B6002709, B6002710, B6002711, B6002712, B6002713, B6002714, B6002715, B6002716, B6002717, B6002718, B6002719, B6002720, B6002722, B6002723, B6002724, B6002725, B6002726, B6002727, B6002728, B6002729, B6002730, B6002732, B6002733, B6002734, B6002735, B6002736, B6002737, B6002746, B6002747, B6002748, B6002749, B6002750, B6002751, B6002752, B6002753, B6002754, B6002755, B6002756, B6002757, B6002758, B6002759, B6002760, B6002761, B6002762, B6002763, B6002764, B6002765, B6002766, B6002767, B6002768, B6002769, B6002770, B6002771, B6002772, B6002773, B6002774, B6002775, B6002777, B6002778, B6002779, B6002781, B6002782, B6002783, B6002784, B6002785, B6002786, B6002787, B6002788, B6002789, B6002790, B6002791, B6002792, B6002793, B6002794, B6002795, B6002796, B6002797, B6002798, B6002799, B6002800, B6002801, B6002803, B6002805, B6002806, B6002807, B6002808, B6002809, B6002810, B6002811, B6002812, B6002813, B6002815, B6002816, B6002817, B6002818, B6002819, B6002820, B6002821, B6002822, B6002823, B6002824, B6002825, B6002826, B6002827, B6002828, B6002829, B6002830, B6002831, B6002832, B6002833, B6002834, B6002835, B6002836, B6002837, B6002838, B6002839, B6002840, B6002841, B6002842, B6002843, B6002844, B6002845, B6002849, B6002857, B6002858, B6002859, B6002860, B6002861, B6002862, B6002863, B6002864, B6002865, B6002866, B6002867, B6002868, B6002869, B6002870, B6002871, B6002872, B6002873, B6002874, B6002875, B6002876, B6002878, B6002879, B6002880, B6002881, B6002882, B6002883, B6002884, B6002885, B6002886, B6002888, B6002889, B6002890, B6002891, and B6002892. ****SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA***** 00001001, 00001007, 00001008, A7001048, A7001069, A7001071, A7001089, A7001090, A7001091, A7001092, A7001095, A7001096, A7001097, A7001100, A7001102, A7001103, A7001106, A7001107, A7001108, A7001109, A7001110, A7001111, A7001112, A7001113, A7001114, A7001115, A7001133, A7001136, A7001263, A7001280, A7001282, A7001442, A7001443, A7001444, A7001720, A7001796, A7001797, A7001798, A7001799, A7001829, A7001830, A7001831, A7001832, A7001833, A7001834, A7001835, A7001838, A7001839, A7001840, A7001849, A7001850, A7001851, A7001852, A7001853, A7001854, A7001855, A7001856, B6001063, B6001064, B6001075, B6001079, B6001081, B6001188, B6001189, B6001211, B6001224, B6001233, B6001251, B6001289, B6001294, B6001296, B6001300, B6001337, B6001347, B6001353, B6001368, B6001371, B6001380, B6001383, B6001391, B6001393, B6001394, B6001395, B6001405, B6001412, B6001413, B6001416, B6001418, B6001432, B6001446, B6001447, B6001454, B6001465, B6001466, B6001475, B6001476, B6001517, B6001534, B6001539, B6001540, B6001548, B6001551, B6001552, B6001556, B6001607, B6001625, B6001671, B6001684, B6001690, B6001714, B6001732, B6001745, B6001749, B6001760, B6001763, B6001775, B6001784, B6001785, B6001786, B6001789, B6001792, B6001802, B6001847, B6001886, B6001929, B6001933, B6001970, B6001971, B6001985, B6002053, B6002056, B6002166, B6002167, B6002194, B6002250, B6002290, B6002291, B6002330, B6002333, B6002344, B6002372, B6002409, B6002410, B6002450, B6002453, B6002454, B6002455, B6002456, B6002523, B6002532, B6002533, B6002552, B6002567, B6002568, B6002569, B6002570, B6002571, B6002572, B6002573, B6002574, B6002575, B6002576, B6002577, B6002578, B6002579, B6002580, B6002581, B6002582, B6002583, B6002584, B6002585, B6002586, B6002587, B6002588, B6002589, B6002590, B6002591, B6002592, B6002593, B6002594, B6002595, B6002596, B6002597, B6002598, B6002599, B6002600, B6002601, B6002603, B6002604, B6002605, B6002606, B6002607, B6002608, B6002609, B6002610, B6002611, B6002612, B6002613, B6002614, B6002615, B6002616, B6002617, B6002618, B6002619, B6002620, B6002621, B6002622, B6002623, B6002624, B6002625, B6002626, B6002627, B6002628, B6002629, B6002630, B6002631, B6002632, B6002633, B6002634, B6002635, B6002636, B6002637, B6002638, B6002639, B6002640, B6002641, B6002642, B6002643, B6002644, B6002645, B6002646, B6002647, B6002648, B6002649, B6002650, B6002651, B6002652, B6002653, B6002654, B6002655, B6002656, B6002657, B6002658, B6002659, B6002660, B6002661, B6002662, B6002663, B6002664, B6002665, B6002666, B6002706, B6002731, B6002738, B6002739, B6002740, B6002741, B6002742, B6002743, B6002744, B6002802, B6002804, and B6002877.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Verathon

All 13

Reported	Class	Recall	Company	Reason	Where
12 Jun 2024Device	CLASS II	GlideScope Core Monitor recalled by Verathon	Verathon	Potency & Assay	42 states
12 Jun 2024Device	CLASS II	GlideScope Core FHD recalled by Verathon	Verathon	Potency & Assay	42 states
9 Dec 2020Device	CLASS II	BladderScan Prime Plus Probe recalled by Verathon	Verathon	Device Malfunction	Nationwide
15 Jul 2020Device	CLASS I	GlideScope Core OneTouch Smart Cable recalled by Verathon	Verathon	Other	Nationwide
18 Mar 2020Device	CLASS II	GlideScope Video Laryngoscope recalled by Verathon	Verathon	Other	33 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide