Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded ...
FDA Device Recall #Z-2201-2026 - Class II, April 8, 2026
Recall Summary
| Recall Number | Z-2201-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 8, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Neuromodulation |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 10165 units |
Product Description
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Reason for Recall
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Software application (app) version 1.x and 2.x, loaded on the following units: 1. Model Number CT900A, GTIN 00643169890923, Serial Numbers: NPL0004445; 2. Model Number CT900B, GTIN 00643169890947, Serial Numbers: NPL1000042, NPL1000045, NPL1000046, NPL1000048, NPL1000050, NPL1000051, NPL1000053, NPL1000054, NPL1000059, NPL1000060, NPL1000062, NPL1000065, NPL1000069, NPL1000070, NPL1000071, NPL1000072, NPL1000073, NPL1000074, NPL1000075, NPL1000077, NPL1000081, NPL1000082, NPL1000083, NPL1000085, NPL1000086, NPL1000087, NPL1000090, NPL1000091, NPL1000093, NPL1000094, NPL1000098, NPL1000117, NPL1000133, NPL1000135, NPL1000137, NPL1000138, NPL1000151, NPL1000159, NPL1000160, NPL1000164, NPL1000166, NPL1000167, NPL1000169, NPL1000173, NPL1000174, NPL1000179, NPL1000180, NPL1000183, NPL1000185, NPL1000186, NPL1000187, NPL1000188, NPL1000191, NPL1000192, NPL1000193, NPL1000194, NPL1000195, NPL1000196, NPL1000230, NPL1000235, NPL1000237, NPL1000242, NPL1000244, NPL1000245, NPL1000246, NPL1000248, NPL1000249, NPL1000252, NPL1000254, NPL1000257, NPL1000258, NPL1000281, NPL1000292, NPL1000297, NPL1000301, NPL1000303, NPL1000307, NPL1000321, NPL1000322, NPL1000323, NPL1000325, NPL1000326, NPL1000332, NPL1000334, NPL1000343, NPL1000361, NPL1000362, NPL1000363, NPL1000364, NPL1000365, NPL1000366, NPL1000367, NPL1000369, NPL1000370, NPL1000381, NPL1000483, NPL1000486, NPL1000487, NPL1000501, NPL1000502, NPL1000505, NPL1000506, NPL1000507, NPL1000509, NPL1000510, NPL1000512, NPL1000515, NPL1000516, NPL1000518, NPL1000519, NPL1000528, NPL1000529, NPL1000539, NPL1000540, NPL1000555, NPL1000556, NPL1000558, NPL1000560, NPL1000561, NPL1000562, NPL1000563, NPL1000564, NPL1000571, NPL1000573, NPL1000574, NPL1000575, NPL1000576, NPL1000577, NPL1000578, NPL1000580, NPL1000585, NPL1000592, NPL1000603, NPL1000606, NPL1000612, NPL1000627, NPL1000630, NPL1000631, NPL1000632, NPL1000634, NPL1000637, NPL1000641, NPL1000652, NPL1000653, NPL1001194, NPL1001195, NPL1001201, NPL1001204, NPL1001205, NPL1001206, NPL1001207, NPL1001208, NPL1001210, NPL1001211, NPL1001212, NPL1001216, NPL1001223, NPL1001224, NPL1001225, NPL1001226, NPL1001228, NPL1001229, NPL1001230, NPL1001231, NPL1001235, NPL1001236, NPL1001237, NPL1001238, NPL1001240, NPL1001241, NPL1001243, NPL1001244, NPL1001250, NPL1001251, NPL1001254, NPL1001259, NPL1001264, NPL1001265, NPL1001272, NPL1001273, NPL1001274, NPL1001277, NPL1001282, NPL1001283, NPL1001290, NPL1001291, NPL1001306, NPL1001307, NPL1001313, NPL1001314, NPL1001328, NPL1001330, NPL1001332, NPL1001333, NPL1001334, NPL1001336, NPL1001337, NPL1001339, NPL1001341, NPL1001345, NPL1001349, NPL1001350, NPL1001351, NPL1001353, NPL1001354, NPL1001360, NPL1001361, NPL1001362, NPL1001366, NPL1001367, NPL1001369, NPL1001372, NPL1001375, NPL1001380, NPL1001381, NPL1001385, NPL1001386, NPL1001389, NPL1001398, NPL1001407, NPL1001408, NPL1001410, NPL1001412, NPL1001419, NPL1001421, NPL1001423, NPL1001430, NPL1001431, NPL1001434, NPL1001435, NPL1001436, NPL1001439, NPL1001445, NPL1001449, NPL1001458, NPL1001461, NPL1001464, NPL1001465, NPL1001468, NPL1001482, NPL1001483, NPL1001486, NPL1001499, NPL1001500, NPL1001505, NPL1001507, NPL1001510, NPL1001512, NPL1001513, NPL1001514, NPL1001518, NPL1001520, NPL1001524, NPL1001526, NPL1001531, NPL1001532, NPL1001537, NPL1001539, NPL1001540, NPL1001541, NPL1001542, NPL1001544, NPL1001545, NPL1001546, NPL1001547, NPL1001549, NPL1001550, NPL1001678, NPL1001689, NPL1001694, NPL1001695, NPL1001697, NPL1001699, NPL1001700, NPL1001701, NPL1001702, NPL1001705, NPL1001707, NPL1001708, NPL1001709, NPL1001710, NPL1001711, NPL1001716, NPL1001717, NPL1001723, NPL1001724, NPL1001727, NPL1001728, NPL1001739, NPL1001740, NPL1001741, NPL1001742, NPL1001743, NPL1001744, NPL1001745, NPL1001748, NPL1001749, NPL1001750, NPL1001754, NPL1001755, NPL1001756, NPL1001757, NPL1001759, NPL1001760, NPL1001761, NPL1001763, NPL1001764, NPL1001765, NPL1001766, NPL1001767, NPL1001769, NPL1001770, NPL1001773, NPL1001777, NPL1001784, NPL1001787, NPL1001789, NPL1001792, NPL1001794, NPL1001795, NPL1001797, NPL1001798, NPL1001799, NPL1001800, NPL1001801, NPL1001803, NPL1001804, NPL1001805, NPL1001806, NPL1001811, NPL1001812, NPL1001815, NPL1001816, NPL1001817, NPL1001820, NPL1001823, NPL1001824, NPL1001825, NPL1001829, NPL1001830, NPL1001833, NPL1001841, NPL1001842, NPL1001843, NPL1001844, NPL1001847, NPL1001875, NPL1001876, NPL1001877, NPL1001879, NPL1001880, NPL1001881, NPL1001882, NPL1001884, NPL1001885, NPL1001886, NPL1001887, NPL1001888, NPL1001889, NPL1001891, NPL1001897, NPL1001899, NPL1001900, NPL1001901, NPL1001903, NPL1001904, NPL1001905, NPL1001937, NPL1001940, NPL1001946, NPL1001947, NPL1001948, NPL1001950, NPL1001955, NPL1001957, NPL1001959, NPL1001963, NPL1001966, NPL1001968, NPL1001969, NPL1001970, NPL1001971, NPL1001972, NPL1001973, NPL1001974, NPL1001975, NPL1001976, NPL1001977, NPL1001995, NPL1001996, NPL1002004, NPL1002007, NPL1002010, NPL1002016, NPL1002020, NPL1002021, NPL1002025, NPL1002034, NPL1002035, NPL1002038, NPL1002048, NPL1002049, NPL1002050, NPL1002051, NPL1002053, NPL1002054, NPL1002064, NPL1002065, NPL1002066, NPL1002067, NPL1002068, NPL1002088, NPL1002089, NPL1002090, NPL1002091, NPL1002092, NPL1002093, NPL1002094, NPL1002095, NPL1002124, NPL1002126, NPL1002132, NPL1002137, NPL1002146, NPL1002152, NPL1002190, NPL1002191, NPL1002192, NPL1002194, NPL1002200, NPL1002203, NPL1002211, NPL1002214, NPL1002219, NPL1002221, NPL1002222, NPL1002223, NPL1002224, NPL1002225, NPL1002226, NPL1002227, NPL1002228, NPL1002229, NPL1002230, NPL1002231, NPL1002232, NPL1002233, NPL1002234, NPL1002236, NPL1002238, NPL1002239, NPL1002240, NPL1002243, NPL1002244, NPL1002245, NPL1002246, NPL1002247, NPL1002254, NPL1002255, NPL1002256, NPL1002311, NPL1002312, NPL1002313, NPL1002316, NPL1002324, NPL1002329, NPL1002330, NPL1002334, NPL1002335, NPL1002337, NPL1002338, NPL1002339, NPL1002340, NPL1002341, NPL1002342, NPL1002343, NPL1002344, NPL1002347, NPL1002349, NPL1002355, NPL1002356, NPL1002357, NPL1002358, NPL1002359, NPL1002360, NPL1002361, NPL1002362, NPL1002363, NPL1002364, NPL1002367, NPL1002368, NPL1002369, NPL1002370, NPL1002371, NPL1002373, NPL1002375, NPL1002380, NPL1002381, NPL1002382, NPL1002383, NPL1002386, NPL1002392, NPL1002396, NPL1002399, NPL1002401, NPL1002405, NPL1002408, NPL1002409, NPL1002410, NPL1002411, NPL1002412, NPL1002413, NPL1002414, NPL1002415, NPL1002416, NPL1002417, NPL1002418, NPL1002421, NPL1002427, NPL1002428, NPL1002431, NPL1002436, NPL1002438, NPL1002443, NPL1002445, NPL1002460, NPL1002461, NPL1002462, NPL1002464, NPL1002465, NPL1002466, NPL1002467, NPL1002470, NPL1002471, NPL1002474, NPL1002482, NPL1002484, NPL1002490, NPL1002491, NPL1002495, NPL1002496, NPL1002499, NPL1002500, NPL1002501, NPL1002502, NPL1002503, NPL1002505, NPL1002508, NPL1002521, NPL1002530, NPL1002537, NPL1002540, NPL1002544, NPL1002545, NPL1002548, NPL1002549, NPL1002555, NPL1002556, NPL1002557, NPL1002564, NPL1002567, NPL1002568, NPL1002572, NPL1002592, NPL1002593, NPL1002594, NPL1002595, NPL1002596, NPL1002613, NPL1002616, NPL1002617, NPL1002618, NPL1002620, NPL1002626, NPL1002628, NPL1002630, NPL1002631, NPL1002632, NPL1002636, NPL1002637, NPL1002638, NPL1002639, NPL1002640, NPL1002642, NPL1002646, NPL1002648, NPL1002650, NPL1002651, NPL1002652, NPL1002653, NPL1002654, NPL1002656, NPL1002659, NPL1002661, NPL1002666, NPL1002668, NPL1002669, NPL1002671, NPL1002673, NPL1002677, NPL1002679, NPL1002684, NPL1002685, NPL1002686, NPL1002687, NPL1002689, NPL1002690, NPL1002693, NPL1002695, NPL1002696, NPL1002698, NPL1002706, NPL1002709, NPL1002710, NPL1002711, NPL1002712, NPL1002714, NPL1002718, NPL1002719, NPL1002720, NPL1002721, NPL1002728, NPL1002729, NPL1002730, NPL1002731, NPL1002732, NPL1002733, NPL1002735, NPL1002736, NPL1002737, NPL1002739, NPL1002740, NPL1002741, NPL1002743, NPL1002753, NPL1002756, NPL1002757, NPL1002760, NPL1002761, NPL1002778, NPL1002779, NPL1002780, NPL1002781, NPL1002784, NPL1002786, NPL1002787, NPL1002789, NPL1002791, NPL1002792, NPL1002794, NPL1002796, NPL1002800; 3. Model Number CT900C, GTIN 00643169890961, Serial Numbers: NPL1000429, NPL1000430, NPL1000442, NPL1000443, NPL1000444, NPL1000445, NPL1000446, NPL1000447, NPL1000448, NPL1000451, NPL1000453, NPL1000771, NPL1000774, NPL1000776, NPL1000777, NPL1000780, NPL1000781, NPL1000794, NPL1000795, NPL1000797, NPL1000798, NPL1000799, NPL1000802, NPL1000804, NPL1000805, NPL1000806, NPL1000808, NPL1000809, NPL1000810, NPL1000811, NPL1000813, NPL1000814, NPL1000815, NPL1000817, NPL1000818, NPL1000819, NPL1000827, NPL1000830, NPL1000832, NPL1000833, NPL1000834, NPL1000835, NPL1000838, NPL1000845, NPL1000847, NPL1000854, NPL1000855, NPL1000858, NPL1001552, NPL1001562, NPL1001564, NPL1001565, NPL1001566, NPL1001570, NPL1001571, NPL1001574, NPL1001582, NPL1001583, NPL1001588, NPL1001590, NPL1001591, NPL1001592, NPL1001594, NPL1001595, NPL1001596, NPL1001601, NPL1001602, NPL1001605, NPL1001606, NPL1001607, NPL1001608, NPL1001609, NPL1001610, NPL1001611, NPL1001615, NPL1001617, NPL1001618, NPL1001620, NPL1001621, NPL1001627, NPL1001629, NPL1001630, NPL1001631, NPL1001632, NPL1001637, NPL1001638, NPL1001644, NPL1001645, NPL1001647, NPL1001649, NPL1001650, NPL1001651, NPL1001652, NPL1001656, NPL1001657, NPL1001670, NPL1001673, NPL1001675, NPL1002257, NPL1002259, NPL1002260, NPL1002262, NPL1002264, NPL1002265, NPL1002266, NPL1002267, NPL1002268, NPL1002275, NPL1002279, NPL1002280, NPL1002281, NPL1002282, NPL1002284, NPL1002285, NPL1002286, NPL1002288, NPL1002294, NPL1002295, NPL1002297, NPL1002298, NPL1002306, NPL1002307, NPL1002308, NPL1002309, NPL1002310; 4. Model Number CT900D, (1) GTIN 00763000077730, Serial Numbers: NPL3000277, NPL3000278, NPL3000279, NPL3000280, NPL3000281, NPL3000282, NPL3000283, NPL3000285, NPL3000290, NPL3000292, NPL3000293, NPL3000298, NPL3000299, NPL3000300, NPL3000301, NPL3000304, NPL3000305, NPL3000309, NPL3000310, NPL3000312, NPL3000460, NPL3000555, NPL3000563, NPL3000582, NPL3000590, NPL3000591, NPL3002090, NPL3002102, NPL3002311, NPL3002312, NPL3002313, NPL3002314, NPL3002315, NPL3002316, NPL3002318, NPL3002760, NPL3002761, NPL3002762, NPL3002763, NPL3002816, NPL3002995, NPL3002997, NPL3002998, NPL3002999, NPL3003000, NPL3003001, NPL3003002, NPL3003003, NPL3003004, NPL3003005, NPL3003009, NPL3003010, NPL3003011, NPL3003012, NPL3003013, NPL3003014, NPL3003015, NPL3003016, NPL3003018, NPL3003021, NPL3003022, NPL3003023, NPL3003024, NPL3003026, NPL3003028, NPL3003029, NPL3003030, NPL3003031, NPL3003032, NPL3003036, NPL3003037, NPL3003038, NPL3003042, NPL3003046, NPL3003048, NPL3003050, NPL3003051, NPL3003054, NPL3003059, NPL3003060, NPL3003062, NPL3003065, NPL3003067, NPL3003068, NPL3003070, NPL3003072, NPL3003073, NPL3003074, NPL3003076, NPL3003077, NPL3003078, NPL3003086, NPL3003260, NPL3003267, NPL3003268, NPL3003271, NPL3003275, NPL3003277, NPL3003280, NPL3003282, NPL3003283, NPL3003284, NPL3003402, NPL3003409, NPL3003412, NPL3003413, NPL3003415, NPL3003416, NPL3003417, NPL3003418, NPL3003419, NPL3003420, NPL3003422, NPL3003423, NPL3003425, NPL3003427, NPL3003513, NPL3003517, NPL3003518, NPL3003521, NPL3003524, NPL3003528, NPL3003529, NPL3003530, NPL3003532, NPL3003533, NPL3003534, NPL3003535, NPL3003536, NPL3003537, NPL3003538, NPL3003539, NPL3003540, NPL3003542, NPL3003543, NPL3003544, NPL3003545, NPL3003546, NPL3003547, NPL3003548, NPL3003549, NPL3003551, NPL3003552, NPL3003558, NPL3003560, NPL3003566, NPL3003567, NPL3003569, NPL3003570, NPL3003576, NPL3003577, NPL3003578, NPL3003579, NPL3003580, NPL3003581, NPL3003598, NPL3003599, NPL3003601, NPL3003745, NPL3003756, NPL3003766, NPL3003817, NPL3003821, NPL3003823, NPL3003824, NPL3003850, NPL3003885, NPL3003886, NPL3003887, NPL3003890, NPL3003891, NPL3003892, NPL3003893, NPL3003894, NPL3003895, NPL3003896, NPL3003897, NPL3003899, NPL3003900, NPL3003901, NPL3003904, NPL3003905, NPL3003906, NPL3003907, NPL3003921, NPL3003923, NPL3003924, NPL3003929, NPL3003943, NPL3003944, NPL3003951, NPL3003952, NPL3003954, NPL3004050, NPL3004052, NPL3004053, NPL3004057, NPL3004061, NPL3004062, NPL3004063, NPL3004064, NPL3004066, NPL3004067, NPL3004068, NPL3004069, NPL3004071, NPL3004072, NPL3004076, NPL3004078, NPL3004081, NPL3004082, NPL3004087, NPL3004095, NPL3004096, NPL3004102, NPL3004114, NPL3004117, NPL3004118, NPL3004139, NPL3004140, NPL3004141, NPL3004143, NPL3004144, NPL3004145, NPL3004146, NPL3004148, NPL3004149, NPL3004151, NPL3004152, NPL3004153, NPL3004340, NPL3004342, NPL3004344, NPL3004345, NPL3004352, NPL3004353, NPL3004417, NPL3004421, NPL3004436, NPL3004793, NPL3004841, NPL3004860, NPL3004871, NPL3004879, NPL3004895, NPL3004897, NPL3004905, NPL3004910, NPL3004913, NPL3004914, NPL3004918, NPL3004925, NPL3004942, NPL3004951, NPL3004952, NPL3004960, NPL3004969, NPL3004971, NPL3004992, NPL3005006, NPL3005009, NPL3005010, NPL3005018, NPL3005025, NPL3005033, NPL3005044, NPL3005053, NPL3005054, NPL3005059, NPL3005060, NPL3005061, NPL3005065, NPL3005075, NPL3005136, NPL3005187, NPL3005199, NPL3005750, NPL3005752, NPL3005760, NPL3005769, NPL3005773, NPL3005779, NPL3005782, NPL3005783, NPL3005785, NPL3005790, NPL3005799, NPL3005801, NPL3005811, NPL3005814, NPL3005817, NPL3005818, NPL3005866, NPL3005876, NPL3005889, NPL3005893, NPL3006002, NPL3006011, NPL3006027, NPL3006033, NPL3006069, NPL3006072, NPL3006084, NPL3006132, NPL3006142, NPL3006146, NPL3006147, NPL3006148, NPL3006151, NPL3006152, NPL3006153, NPL3006155, NPL3006160, NPL3006161, NPL3006167, NPL3006168, NPL3006176, NPL3006179, NPL3006181, NPL3006188, NPL3006189, NPL3006190, NPL3006192, NPL3006194, NPL3006198, NPL3006203, NPL3006205, NPL3006209, NPL3006213, NPL3006217, NPL3006221, NPL3006225, NPL3006230, NPL3006237, NPL3006238, NPL3006242, NPL3006245, NPL3006247, NPL3006248, NPL3006249, NPL3006250, NPL3006253, NPL3006254, NPL3006255, NPL3006267, NPL3006279, NPL3006280, NPL3006289, NPL3006305, NPL3006309, NPL3006310, NPL3006312, NPL3006359, NPL3006360, NPL3006361, NPL3006366, NPL3006372, NPL3006374, NPL3006375, NPL3006377, NPL3006379, NPL3006380, NPL3006381, NPL3006389, NPL3006391, NPL3006392, NPL3006393, NPL3006394, NPL3006399, NPL3006400, NPL3006406, NPL3006407, NPL3006408, NPL3006410, NPL3006413, NPL3006414, NPL3006416, NPL3006417, NPL3006433, NPL3006443, NPL3006445, NPL3006446, NPL3006448, NPL3006449, NPL3006450, NPL3006452, NPL3006453, NPL3006454, NPL3006457, NPL3006458, NPL3006461, NPL3006465, NPL3006468, NPL3006469, NPL3006475, NPL3006476, NPL3006485, NPL3006486, NPL3006487, NPL3006489, NPL3006490, NPL3006491, NPL3006492, NPL3006494, NPL3006495, NPL3006496, NPL3006498, NPL3006513, NPL3006516, NPL3006518, NPL3006519, NPL3006520, NPL3006522, NPL3006523, NPL3006524, NPL3006525, NPL3006526, NPL3006527, NPL3006531, NPL3006532, NPL3006533, NPL3006534, NPL3006536, NPL3006572, NPL3006581, NPL3006586, NPL3006587, NPL3006600, NPL3006601, NPL3006602, NPL3006604, NPL3006605, NPL3006608, NPL3006612, NPL3006620, NPL3006625, NPL3006626, NPL3006627, NPL3006634, NPL3006825, NPL3006827, NPL3006885, NPL3006886, NPL3006887, NPL3006888, NPL3006889, NPL3006900, NPL3006902, NPL3006904, NPL3006909, NPL3006911, NPL3006917, NPL3006918, NPL3006920, NPL3006921, NPL3006922, NPL3006923, NPL3006924, NPL3006930, NPL3006932, NPL3006933, NPL3006934, NPL3006936, NPL3006938, NPL3006944, NPL3006946, NPL3006947, NPL3006948, NPL3006949, NPL3006950, NPL3006951, NPL3006952, NPL3006953, NPL3006954, NPL3006955, NPL3006962, NPL3006963, NPL3006964, NPL3006966, NPL3006967, NPL3006968, NPL3006971, NPL3006972, NPL3006974, NPL3006977, NPL3006979, NPL3006982, NPL3006983, NPL3006985, NPL3006986, NPL3007004, NPL3007011, NPL3007012, NPL3007053, NPL3007268, NPL3007269, NPL3007272, NPL3007273, NPL3007274, NPL3007276, NPL3007277, NPL3007362, NPL3007363, NPL3007365, NPL3007366, NPL3007367, NPL3007368, NPL3007370, NPL3007371, NPL3007372, NPL3007384, NPL3007385, NPL3007393, NPL3007439, NPL3007451, NPL3007453, NPL3007455, NPL3007456, NPL3007457, NPL3007458, NPL3007464, NPL3007465, NPL3007583, NPL3007584, NPL3007585, NPL3007589, NPL3007592, NPL3007593, NPL3007594, NPL3007596, NPL3007601, NPL3007605, NPL3007608, NPL3007611, NPL3007617, NPL3007619, NPL3007621, NPL3007672, NPL3007677, NPL3007679, NPL3007685, NPL3007688, NPL3007776, NPL3007867, NPL3007869, NPL3007873, NPL3007875, NPL3007877, NPL3007878, NPL3007886, NPL3007887, NPL3007889, NPL3007890, NPL3007895, NPL3007900, NPL3007901, NPL3007904, NPL3007907, NPL3007908, NPL3007909, NPL3007910, NPL3007914, NPL3007916, NPL3007917, NPL3007918, NPL3007921, NPL3007924, NPL3007926, NPL3007927, NPL3007929, NPL3007930, NPL3007937, NPL3007947, NPL3007948, NPL3008029, NPL3008031, NPL3008033, NPL3008034, NPL3008036, NPL3008039, NPL3008046, NPL3008048, NPL3008053, NPL3008058, NPL3008068, NPL3010566, NPL3010568, NPL3010569, NPL3010570, NPL3010573, NPL3010578, NPL3010588, NPL3010593, NPL3010607, NPL3010628, NPL3010629, NPL3010631, NPL3010642, NPL3010645, NPL3010647, NPL3010652, NPL3010653, NPL3010658, NPL3010660, NPL3010665, NPL3010683, NPL3010688, NPL3010690, NPL3010691, NPL3010692, NPL3010782, NPL3010784, NPL3010786, NPL3010793, NPL3010800, NPL3010806, NPL3010817, NPL3010820, NPL3010824, NPL3010828, NPL3010829, NPL3010831, NPL3010833, NPL3010835, NPL3010866, NPL3010874, NPL3010876, NPL3010877, NPL3010879, NPL3010880, NPL3010887, NPL3010891, NPL3010892, NPL3010901, NPL3010902, NPL3010904, NPL3010907, NPL3010908, NPL3010910, NPL3010911, NPL3010914, NPL3010915, NPL3010927, NPL3010928, NPL3010934, NPL3010940, NPL3010945, NPL3010946, NPL3010953, NPL3010954, NPL3010955, NPL3010958, NPL3010968, NPL3010991, NPL3010996, NPL3010997, NPL3010998, NPL3011008, NPL3011104, NPL3011106, NPL3011107, NPL3011108, NPL3011109, NPL3011113, NPL3011169, NPL3011217, NPL3011219, NPL3011221, NPL3011224, NPL3011226, NPL3011227, NPL3011228, NPL3011234, NPL3011235, NPL3011236, NPL3011239, NPL3011240, NPL3011241, NPL3011242, NPL3011243, NPL3011244, NPL3011245, NPL3011246, NPL3011247, NPL3011249, NPL3011267, NPL3011269, NPL3011286, NPL3011287, NPL3011367, NPL3011426, NPL3011427, NPL3011428, NPL3011429, NPL3011430, NPL3011434, NPL3011435, NPL3011436, NPL3011437, NPL3011445, NPL3011446, NPL3011447, NPL3011448, NPL3011449, NPL3011452, NPL3011459, NPL3011460, NPL3011462, NPL3011463, NPL3011481, NPL3011482, NPL3011485, NPL3011487, NPL3011489, NPL3011490, NPL3011568, NPL3011569, NPL3011572, NPL3011573, NPL3011574, NPL3011575, NPL3011587, NPL3011589, NPL3011590, NPL3011600, NPL3011602, NPL3011605, NPL3011606, NPL3011607, NPL3011632, NPL3011633, NPL3011637, NPL3011639, NPL3011651, NPL3011652, NPL3011653, NPL3011656, NPL3011701, NPL3011703, NPL3011704, NPL3011705, NPL3011706, NPL3011707, NPL3011708, NPL3011709, NPL3011716, NPL3011718, NPL3011719, NPL3011720, NPL3011725, NPL3011734, NPL3011738, NPL3011739, NPL3011741, NPL3011749, NPL3011750, NPL3011753, NPL3011754, NPL3011756, NPL3011757, NPL3011762, NPL3013178, NPL3013655, NPL3013656, NPL3013665, NPL3013669, NPL3013670, NPL3013671, NPL3013674, NPL3013675, NPL3013676, NPL3013679, NPL3013680, NPL3013683, NPL3013684, NPL3013687, NPL3013699, NPL3013702, NPL3013712, NPL3013713, NPL3013714, NPL3013715, NPL3013717, NPL3013719, NPL3013721, NPL3013740, NPL3013743, NPL3013746, NPL3013748, NPL3013751, NPL3013754, NPL3013755, NPL3013758, NPL3013759, NPL3013760, NPL3013762, NPL3013763, NPL3013764, NPL3013766, NPL3013767, NPL3013768, NPL3013769, NPL3013773, NPL3013781, NPL3013783, NPL3013786, NPL3013795, NPL3013796, NPL3013797, NPL3013798, NPL3013799, NPL3013817, NPL3013818, NPL3013819, NPL3013821, NPL3013825, NPL3013826, NPL3013827, NPL3013830, NPL3013856, NPL3013857, NPL3013858, NPL3013860, NPL3013861, NPL3013862, NPL3013863, NPL3013864, NPL3013865, NPL3013871, NPL3013875, NPL3013876, NPL3013877, NPL3013878, NPL3013879, NPL3013890, NPL3013895, NPL3013896, NPL3013897, NPL3013901, NPL3013903, NPL3013904, NPL3013905, NPL3013906, NPL3013913, NPL3013916, NPL3013920, NPL3013923, NPL3013931, NPL3013932, NPL3013933, NPL3013935, NPL3013936, NPL3013937, NPL3013938, NPL3013939, NPL3013940, NPL3013941, NPL3013942, NPL3013943, NPL3013944, NPL3013949, NPL3013952, NPL3013953, NPL3013954, NPL3013960, NPL3013961, NPL3013962, NPL3013963, NPL3013964, NPL3013965, NPL3013966, NPL3013967, NPL3013969, NPL3013970, NPL3013971, NPL3013979, NPL3014238, NPL3014289, NPL3014291, NPL3014296, NPL3014297, NPL3014298, NPL3014299, NPL3014304, NPL3014307, NPL3014309, NPL3014311, NPL3014315, NPL3014317, NPL3014319, NPL3014321, NPL3014322, NPL3014323, NPL3014324, NPL3014326, NPL3014328, NPL3014330, NPL3014334, NPL3014335, NPL3014340, NPL3014343, NPL3014344, NPL3014457, NPL3014459, NPL3014462, NPL3014466, NPL3014467, NPL3014468, NPL3014521, NPL3014522, NPL3014526, NPL3014543, NPL3014544, NPL3014546, NPL3014573, NPL3014574, NPL3014575, NPL3014580, NPL3014584, NPL3014586, NPL3014588, NPL3014629, NPL3014630, NPL3014638, NPL3014770, NPL3014771, NPL3014772, NPL3014773, NPL3014774, NPL3014775, NPL3014776, NPL3014777, NPL3014778, NPL3014782, NPL3014784, NPL3014785, NPL3014788, NPL3014789, NPL3014791, NPL3014792, NPL3014793, NPL3014794, NPL3014796, NPL3014798, NPL3014799, NPL3014800, NPL3014869, NPL3014886, NPL3014887, NPL3014888, NPL3014889, NPL3014891, NPL3014892, NPL3014895, NPL3014971, NPL3014974, NPL3014975, NPL3014976, NPL3014977, NPL3014978, NPL3014980, NPL3014984, NPL3014988, NPL3014989, NPL3014990, NPL3014991, NPL3014997, NPL3015001, NPL3015005, NPL3015006, NPL3015007, NPL3015008, NPL3015010, NPL3015011, NPL3015014, NPL3015018, NPL3015071, NPL3015072, NPL3015074, NPL3015075, NPL3015076, NPL3015077, NPL3015078, NPL3015079, NPL3015081, NPL3015082, NPL3015083, NPL3015085, NPL3015086, NPL3015087, NPL3015088, NPL3015090, NPL3015091, NPL3015094, NPL3015095, NPL3015096, NPL3015097, NPL3015098, NPL3015099, NPL3015100, NPL3015101, NPL3015105, NPL3015107, NPL3015112, NPL3015113, NPL3015114, NPL3015116, NPL3015127, NPL3015128, NPL3015139, NPL3015140, NPL3015141, NPL3015142, NPL3015143, NPL3015144, NPL3015145, NPL3015146, NPL3015147, NPL3015148, NPL3015149, NPL3015150, NPL3015151, NPL3015152, NPL3015153, NPL3015154, NPL3015155, NPL3015156, NPL3015158, NPL3015160, NPL3015161, NPL3015162, NPL3015165, NPL3015166, NPL3015167, NPL3015168, NPL3015169, NPL3015170, NPL3015171, NPL3015178, NPL3015179, NPL3015184, NPL3015186, NPL3015187, NPL3015188, NPL3015189, NPL3015190, NPL3015261, NPL3015264, NPL3015266, NPL3015267, NPL3015270, NPL3015274, NPL3015275, NPL3015277, NPL3015278, NPL3015279, NPL3015310, NPL3015384, NPL3015385, NPL3015386, NPL3015387, NPL3015388, NPL3015389, NPL3015390, NPL3015391, NPL3015392, NPL3015393, NPL3015394, NPL3015396, NPL3015398, NPL3015399, NPL3015401, NPL3015402, NPL3015403, NPL3015404, NPL3015405, NPL3015406, NPL3015407, NPL3015512, NPL3015559, NPL3015561, NPL3015565; (2) GTIN 00763000094027, Serial Numbers: NPL3000006, NPL3000007, NPL3000009, NPL3000010, NPL3000011, NPL3000012, NPL3000014, NPL3000016, NPL3000017, NPL3000018, NPL3000021, NPL3000023, NPL3000025, NPL3000026, NPL3000029, NPL3000030, NPL3000031, NPL3000033, NPL3000035, NPL3000040, NPL3000043, NPL3000046, NPL3000047, NPL3000048, NPL3000049, NPL3000050, NPL3000055, NPL3000057, NPL3000059, NPL3000062, NPL3000063, NPL3000068, NPL3000071, NPL3000074, NPL3000076, NPL3000077, NPL3000079, NPL3000083, NPL3000093, NPL3000094, NPL3000097, NPL3000103, NPL3000105, NPL3000109, NPL3000111, NPL3000125, NPL3000128, NPL3000129, NPL3000134, NPL3000135, NPL3000143, NPL3000184, NPL3000186, NPL3000188, NPL3000189, NPL3000196, NPL3000197, NPL3000198, NPL3000199, NPL3000202, NPL3000203, NPL3000205, NPL3000206, NPL3000208, NPL3000209, NPL3000210, NPL3000212, NPL3000213, NPL3000214, NPL3000215, NPL3000216, NPL3000219, NPL3000220, NPL3000221, NPL3000222, NPL3000223, NPL3000224, NPL3000226, NPL3000227, NPL3000229, NPL3000230, NPL3000232, NPL3000233, NPL3000236, NPL3000237, NPL3000240, NPL3000241, NPL3000242, NPL3000246, NPL3000248, NPL3000249, NPL3000250, NPL3000252, NPL3000253, NPL3000255, NPL3000258, NPL3000259, NPL3000260, NPL3000261, NPL3000262, NPL3000264, NPL3000265, NPL3002259, NPL3002261, NPL3002262, NPL3002263, NPL3002266, NPL3002270, NPL3002274, NPL3002282, NPL3002284, NPL3002288, NPL3002291, NPL3002293, NPL3002294, NPL3002296, NPL3002300, NPL3002304, NPL3002655, NPL3002659, NPL3002660, NPL3002661, NPL3002662, NPL3002663, NPL3002664, NPL3002665, NPL3002666, NPL3002667, NPL3002668, NPL3002669, NPL3002670, NPL3002671, NPL3002672, NPL3002673, NPL3002674, NPL3002675, NPL3002676, NPL3002677, NPL3002679, NPL3002680, NPL3002681, NPL3002682, NPL3002684, NPL3002685, NPL3002686, NPL3002687, NPL3002688, NPL3002691, NPL3002692, NPL3002693, NPL3002694, NPL3002696, NPL3002697, NPL3002699, NPL3002700, NPL3002701, NPL3002702, NPL3002703, NPL3002704, NPL3002705, NPL3002706, NPL3002707, NPL3002709, NPL3002710, NPL3002711, NPL3002712, NPL3002713, NPL3002715, NPL3002716, NPL3002717, NPL3002718, NPL3002719, NPL3002720, NPL3002721, NPL3002722, NPL3002723, NPL3002724, NPL3002725, NPL3002726, NPL3002727, NPL3002728, NPL3002729, NPL3002730, NPL3002731, NPL3002732, NPL3002733, NPL3002734, NPL3002736, NPL3002737, NPL3002738, NPL3002739, NPL3002741, NPL3002742, NPL3002743, NPL3002745, NPL3002746, NPL3002747, NPL3002749, NPL3002750, NPL3002751, NPL3002752, NPL3002753, NPL3002754, NPL3002755, NPL3002756, NPL3002757, NPL3002872, NPL3002873, NPL3002874, NPL3002875, NPL3002877, NPL3002878, NPL3002879, NPL3002880, NPL3002881, NPL3002882, NPL3002883, NPL3002884, NPL3002885, NPL3002887, NPL3002888, NPL3002891, NPL3002892, NPL3002894, NPL3002898, NPL3002899, NPL3002900, NPL3002901, NPL3002902, NPL3002904, NPL3002906, NPL3002907, NPL3002908, NPL3002909, NPL3002910, NPL3002911, NPL3002913, NPL3002914, NPL3002915, NPL3002918, NPL3002919, NPL3002922, NPL3002924, NPL3002925, NPL3002927, NPL3002928, NPL3002929, NPL3002935, NPL3002940, NPL3002941, NPL3002942, NPL3002949, NPL3002950, NPL3002954, NPL3002955, NPL3002960, NPL3002961, NPL3003298, NPL3003304, NPL3003308, NPL3003310, NPL3003311, NPL3003313, NPL3003315, NPL3003317, NPL3003319, NPL3003324, NPL3003331, NPL3003332, NPL3003334, NPL3003337, NPL3003338, NPL3003339, NPL3003342, NPL3003345, NPL3003346, NPL3003347, NPL3003353, NPL3003354, NPL3003355, NPL3003356, NPL3003357, NPL3003359, NPL3003694, NPL3003696, NPL3003704, NPL3003705, NPL3003708, NPL3003711, NPL3003712, NPL3003713, NPL3003715, NPL3003717, NPL3003718, NPL3003720, NPL3003723, NPL3003729, NPL3003730, NPL3003731, NPL3003735, NPL3003736, NPL3003737, NPL3003741, NPL3003742, NPL3003984, NPL3003987, NPL3003988, NPL3003989, NPL3003990, NPL3007387, NPL3007388, NPL3007390, NPL3007391, NPL3010714, NPL3010717, NPL3010721, NPL3010722, NPL3010724, NPL3010725, NPL3010726, NPL3010732, NPL3010735, NPL3010736, NPL3010739, NPL3010748, NPL3010750, NPL3010752, NPL3010753, NPL3010756, NPL3010758, NPL3010759, NPL3010760, NPL3010761, NPL3010764, NPL3010769, NPL3010770, NPL3010771, NPL3010772, NPL3010774, NPL3010779, NPL3011292, NPL3011296, NPL3011298, NPL3011304, NPL3011309, NPL3011310, NPL3011311, NPL3011313, NPL3011314, NPL3011316, NPL3011317, NPL3011319, NPL3011320, NPL3011323, NPL3011328, NPL3011329, NPL3011330, NPL3011331, NPL3011332, NPL3011333, NPL3011336, NPL3011338, NPL3011343, NPL3011344, NPL3011345, NPL3011346, NPL3011347, NPL3011349, NPL3011350, NPL3011352, NPL3011353, NPL3011357, NPL3011358, NPL3011362, NPL3011363, NPL3011365, NPL3014039, NPL3014040, NPL3014042, NPL3014043, NPL3014045, NPL3014052, NPL3014053, NPL3014054, NPL3014055, NPL3014056, NPL3014057, NPL3014058, NPL3014059, NPL3014061, NPL3014064, NPL3014065, NPL3014066, NPL3014070, NPL3014071, NPL3014072, NPL3014073, NPL3014074, NPL3014076, NPL3014079, NPL3014083, NPL3014085, NPL3014086, NPL3014087, NPL3014095, NPL3014096, NPL3014097, NPL3014098, NPL3014346, NPL3014347, NPL3014454, NPL3014455, NPL3014456, NPL3014501, NPL3014505, NPL3014506, NPL3014508, NPL3014529, NPL3014530, NPL3014537, NPL3014541, NPL3014542, NPL3017239, NPL3017240, NPL3017247, NPL3017252, NPL3017254, NPL3017257, NPL3017260, NPL3017265, NPL3017266, NPL3017267, NPL3017268, NPL3017269, NPL3017270, NPL3017272, NPL3017275, NPL3017284, NPL3017285, NPL3017286, NPL3017287, NPL3017289, NPL3017290, NPL3017932, NPL3017933, NPL3017991, NPL3017992, NPL3017993, NPL3018577, NPL3018578, NPL3018655, NPL3018709, NPL3018711, NPL3018715, NPL3018718, NPL3018719, NPL3018885, NPL3019477, NPL3019531, NPL3019532, NPL3019533, NPL3019534, NPL3019535, NPL3019537, NPL3019539, NPL3019541, NPL3019607, NPL3019660, NPL3019663, NPL3019664, NPL3019666, NPL3019668, NPL3019672, NPL3019677, NPL3019678, NPL3019769, NPL3020210, NPL3021261, NPL3021268, NPL3021270, NPL3021465, NPL3021466, NPL3021467, NPL3021468, NPL3021471, NPL3021479, NPL3021480, NPL3021481, NPL3021485, NPL3021487, NPL3021488, NPL3021490, NPL3021491, NPL3022395, NPL3022399; (3) GTIN 00763000421007, Serial Numbers: NPL3016404, NPL3016409, NPL3016410, NPL3016411, NPL3016418, NPL3016420, NPL3016421, NPL3016422, NPL3016423, NPL3016424, NPL3016428, NPL3016429, NPL3016431, NPL3016435, NPL3016436, NPL3016437, NPL3016438, NPL3016439, NPL3016440, NPL3016441, NPL3016443, NPL3016444, NPL3016446, NPL3016447, NPL3016448, NPL3016449, NPL3016457, NPL3016458, NPL3016460, NPL3016461, NPL3016464, NPL3016465, NPL3016469, NPL3016470, NPL3016475, NPL3016477, NPL3016478, NPL3016479, NPL3016481, NPL3016482, NPL3016484, NPL3016488, NPL3016492, NPL3016493, NPL3016495, NPL3016498, NPL3016499, NPL3016501, NPL3016502, NPL3016504, NPL3016507, NPL3016508, NPL3016513, NPL3016515, NPL3016516, NPL3016517, NPL3016518, NPL3016519, NPL3016522, NPL3016524, NPL3016525, NPL3016526, NPL3016527, NPL3016528, NPL3016529, NPL3016530, NPL3016531, NPL3016535, NPL3016536, NPL3016537, NPL3016539, NPL3016582, NPL3016584, NPL3016592, NPL3016594, NPL3016600, NPL3016601, NPL3016602, NPL3016603, NPL3016606, NPL3016607, NPL3016608, NPL3016613, NPL3016617, NPL3016621, NPL3016699, NPL3016702, NPL3016712, NPL3016713, NPL3016714, NPL3016715, NPL3016716, NPL3016737, NPL3016738, NPL3016743, NPL3016744, NPL3016745, NPL3016746, NPL3016747, NPL3016748, NPL3016749, NPL3016750, NPL3016757, NPL3016761, NPL3016762, NPL3016763, NPL3016765, NPL3016766, NPL3016775, NPL3016776, NPL3016778, NPL3016780, NPL3016784, NPL3016785, NPL3016787, NPL3016788, NPL3016790, NPL3016792, NPL3016793, NPL3016795, NPL3016796, NPL3016797, NPL3016798, NPL3016800, NPL3016801, NPL3016802, NPL3016933, NPL3016995, NPL3017043, NPL3017053, NPL3017201, NPL3017214, NPL3017221, NPL3017224, NPL3017231, NPL3017232, NPL3017303, NPL3017307, NPL3017308, NPL3017309, NPL3017310, NPL3017312, NPL3017313, NPL3017315, NPL3017316, NPL3017320, NPL3017324, NPL3017325, NPL3017333, NPL3017335, NPL3017344, NPL3017346, NPL3017347, NPL3017348, NPL3017349, NPL3017350, NPL3017367, NPL3017384, NPL3017392, NPL3017393, NPL3017402, NPL3017412, NPL3017414, NPL3017424, NPL3017425, NPL3017426, NPL3017427, NPL3017430, NPL3017431, NPL3017444, NPL3017506, NPL3017610, NPL3017611, NPL3017613, NPL3017614, NPL3017620, NPL3017625, NPL3017628, NPL3017629, NPL3017630, NPL3017654, NPL3017660, NPL3017662, NPL3017663, NPL3017664, NPL3017685, NPL3017686, NPL3017692, NPL3017693, NPL3017694, NPL3017695, NPL3017704, NPL3017705, NPL3017706, NPL3017707, NPL3017717, NPL3017726, NPL3017727, NPL3017739, NPL3017744, NPL3017748, NPL3017761, NPL3017767, NPL3017768, NPL3017769, NPL3017770, NPL3017771, NPL3017774, NPL3017779, NPL3017890, NPL3017891, NPL3017895, NPL3017897, NPL3017898, NPL3017900, NPL3017922, NPL3017924, NPL3017926, NPL3017927, NPL3017928, NPL3017942, NPL3017943, NPL3017944, NPL3017995, NPL3017996, NPL3017998, NPL3018002, NPL3018004, NPL3018005, NPL3018006, NPL3018007, NPL3018008, NPL3018009, NPL3018010, NPL3018011, NPL3018012, NPL3018013, NPL3018015, NPL3018016, NPL3018017, NPL3018018, NPL3018019, NPL3018020, NPL3018021, NPL3018022, NPL3018023, NPL3018024, NPL3018025, NPL3018026, NPL3018028, NPL3018045, NPL3018046, NPL3018048, NPL3018049, NPL3018050, NPL3018052, NPL3018053, NPL3018054, NPL3018058, NPL3018059, NPL3018062, NPL3018527, NPL3018528, NPL3018532, NPL3018534, NPL3018537, NPL3018538, NPL3018562, NPL3018563, NPL3018564, NPL3018579, NPL3018602, NPL3018607, NPL3018608, NPL3018609, NPL3018613, NPL3018614, NPL3018617, NPL3018619, NPL3018623, NPL3018626, NPL3018627, NPL3018657, NPL3018659, NPL3018677, NPL3018720, NPL3018721, NPL3018726, NPL3018727, NPL3018728, NPL3018729, NPL3018735, NPL3018736, NPL3018737, NPL3018743, NPL3018747, NPL3018748, NPL3018750, NPL3018751, NPL3018756, NPL3018757, NPL3018759, NPL3018760, NPL3018761, NPL3018762, NPL3018763, NPL3018765, NPL3018769, NPL3018775, NPL3018776, NPL3018777, NPL3018778, NPL3018780, NPL3018784, NPL3018792, NPL3018808, NPL3018809, NPL3018829, NPL3018830, NPL3018831, NPL3018832, NPL3018833, NPL3018834, NPL3018835, NPL3018836, NPL3018839,
Other Recalls from Medtronic Neuromodulation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2241-2026 | Class II | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain... | May 13, 2026 |
| Z-2240-2026 | Class II | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain... | May 13, 2026 |
| Z-1043-2026 | Class II | A71200 Vanta" Clinician Programmer Application ... | Dec 3, 2025 |
| Z-0996-2026 | Class II | Restore Clinician Programmer Application (CP Ap... | Nov 20, 2025 |
| Z-1704-2025 | Class II | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Apr 3, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.