Recall archive / FDA device enforcement

CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmona... — FDA record Z-0218-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 4, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
Reason: Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees.
Classification: Class II
Recalling firm: St. Jude Medical
Quantity: 36,153 units
Agency-reported status: Ongoing
Source record identifier: Z-0218-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model Number CM1100; UDI/DI: 05414734509800; Serial Numbers: P150800220, P150800222, P150800226, P150800240, P150800242, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800273, P150800277, P150900313, P150900315, P150900318, P150900319, P150900322, P150900333, P150900334, P150900335, P150900337, P150900343, P150900344, P150900349, P150900350, P160100406, P160100410, P160100412, P160100414, P160100416, P160100419, P160100422, P160200429, P160200434, P160200435, P160200440, P160200442, P160200451, P160200452, P160200453, P160200456, P160200459, P160200464, P160200466, P160200469, P160200476, P160200479, P160200480, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200498, P160200505, P160200511, P160200512, P160200515, P160200518, P160200521, P160200524, P160200527, P160200528, P160200529, P160200530, P160200535, P160200538, P160200539, P160200540, P160200545, P160200548, P160200552, P160200557, P160200559, P160200565, P160200566, P160200568, P160200569, P160200571, P160200573, P160200575, P160500583, P160500596, P160500597, P160500601, P160500602, P160600606, P160600607, P160600608, P160600609, P160600610, P160600612, P160600621, P160600622, P160600625, P160600626, P160600632, P160600633, P160600636, P160600638, P160600643, P160600646, P160600647, P160600656, P160600658, P160600659, P160600663, P160600664, P160600668, P160600669, P160600676, P160600678, P160600681, P160600682, P160600684, P160600694, P160600695, P160600697, P160600699, P160600700, P160600706, P160600712, P160600714, P160600716, P160600717, P160600719, P160600723, P160600725, P160600727, P160600730, P160600731, P160600732, P160900733, P160900734, P160900736, P160900743, P160900746, P160900747, P160900748, P160900749, P160900750, P160900751, P160900752, P160900758, P160900759, P160900764, P160900765, P160900767, P160900774, P160900776, P160900777, P160900778, P160900779, P160900780, P160900781, P160900782, P160900786, P160900789, P160900792, P161000793, P161000795, P161000800, P161000804, P161000805, P161000806, P161000810, P161000811, P161000812, P161000819, P161000821, P161000828, P161000832, P161000844, P161000846, P161000847, P161000854, P161000855, P161000857, P161000861, P161000862, P161000864, P161000866, P161000884, P161000890, P161000899, P161000900, P161000901, P161000902, P161000906, P161000912, P161000914, P161000915, P161000917, P161000922, P161000926, P161000927, P161000928, P161000931, P161000936, P161000949, P161000954, P161000956, P161000959, P161000961, P161000962, P161000963, P161000965, P161000967, P161000968, P161000971, P161000973, P161000977, P161000978, P161000979, P161000981, P161000983, P161000984, P161000986, P161000988, P161000991, P161000994, P161000998, P161001003, P161001004, P161001007, P161001009, P161001010, P161001012, P161001014, P161001015, P161001017, P161001018, P161001024, P161001025, P161001026, P161001030, P161001032, P161001038, P161001041, P161001042, P161001044, P161001045, P161001046, P161001048, P161001051, P161001053, P161001054, P161001060, P161001062, P161001069, P161001076, P161001078, P161001079, P161001084, P161001085, P161001086, P161001087, P161001091, P161001094, P161001096, P161001098, P161001100, P161001101, P161001102, P161001104, P161001111, P161001112, P161001127, P161001128, P161001130, P161001133, P161001142, P161001147, P161001148, P161001150, P161001152, P161001153, P161001155, P161001157, P161001160, P161001163, P161001164, P161001165, P161001168, P161001169, P161001171, P161001177, P161001178, P161001179, P161001186, P161001187, P161001188, P161001190, P161001191, P161001193, P161001203, P161001204, P161001205, P161001208, P161101223, P161101224, P161101225, P161101236, P161101238, P161101240, P161101241, P161101242, P161101243, P161101244, P161101273, P161101277, P161101280, P161101281, P161101289, P161101290, P161101291, P161101296, P161101297, P161101302, P161101305, P161101312, P161101313, P161101314, P161101315, P161101317, P161101319, P161101321, P161101323, P161101324, P161101331, P161101332, P161101334, P161101339, P161101340, P161101341, P161101342, P161101343, P161101345, P161101348, P161101352, P161101357, P161101359, P161101361, P161101362, P161101363, P161101366, P161101369, P161101376, P161101377, P161101379, P161101382, P161101383, P161101388, P161101389, P161101390, P161101396, P161101397, P161101400, P161101403, P161101404, P161101405, P161101408, P161101410, P161101425, P161101429, P161101431, P161101434, P161101439, P161101440, P161101442, P161101444, P161101449, P161101450, P161101451, P161101452, P161101457, P161101465, P161101466, P161101469, P161101470, P161101471, P161101472, P161101474, P161101481, P161101487, P161101488, P161101490, P161101491, P161101492, P161101494, P161101499, P161101502, P161101504, P161101509, P161101510, P161101514, P161101520, P161101526, P161101527, P161101530, P161101531, P161101533, P161101541, P161101542, P161101551, P161101553, P161101554, P161101555, P161101557, P161101562, P161101564, P161101566, P161101570, P161101571, P161201573, P161201584, P161201586, P161201588, P161201589, P161201591, P161201594, P161201599, P161201605, P161201608, P161201609, P161201610, P161201617, P161201618, P161201622, P161201623, P161201625, P161201630, P161201634, P161201642, P161201643, P161201644, P161201645, P161201647, P161201650, P161201652, P161201653, P161201654, P161201656, P161201658, P161201660, P161201698, P161201699, P161201704, P161201705, P161201707, P161201708, P161201712, P161201718, P161201719, P161201720, P161201721, P161201722, P161201727, P161201733, P161201735, P161201736, P161201742, P161201744, P161201745, P161201747, P161201749, P161201750, P161201752, P161201758, P161201760, P161201761, P161201764, P161201765, P161201769, P161201770, P161201785, P161201788, P161201789, P161201790, P161201794, P170101817, P170101818, P170101822, P170101826, P170101828, P170101829, P170101835, P170101836, P170101837, P170101842, P170101843, P170101845, P170101850, P170101851, P170101852, P170101853, P170101855, P170101856, P170101857, P170101858, P170101866, P170101867, P170101869, P170101873, P170101874, P170101875, P170101876, P170101878, P170101883, P170101884, P170101885, P170101886, P170101889, P170101891, P170101894, P170101897, P170101898, P170101916, P170101918, P170101921, P170101931, P170101933, P170101935, P170101954, P170101955, P170101957, P170101959, P170101963, P170101967, P170101977, P170101978, P170101980, P170101984, P170101990, P170101992, P170101993, P170101994, P170101995, P170101998, P170101999, P170102000, P170102005, P170102011, P170102015, P170102017, P170102019, P170102020, P170102029, P170102031, P170102032, P170102038, P170102042, P170102045, P170102048, P170102049, P170102052, P170102053, P170102055, P170102058, P170102060, P170102062, P170102067, P170102068, P170102070, P170102081, P170102085, P170102086, P170102090, P170102091, P170102092, P170102093, P170102097, P170102103, P170102105, P170102106, P170102110, P170102112, P170102114, P170102115, P170102121, P170102122, P170102128, P170102129, P170102130, P170102134, P170102136, P170102144, P170102152, P170102153, P170102164, P170102170, P170102171, P170102175, P170102199, P170102201, P170102206, P170102209, P170102210, P170102212, P170102214, P170102218, P170102224, P170102226, P170102229, P170102232, P170102237, P170102243, P170102245, P170102247, P170102259, P170102261, P170102263, P170102264, P170102272, P170102273, P170102278, P170102281, P170102284, P170102289, P170102290, P170102291, P170102298, P170202302, P170202306, P170202309, P170202310, P170202311, P170202312, P170202315, P170202318, P170202320, P170202325, P170202328, P170202330, P170202331, P170202332, P170202333, P170202335, P170202336, P170202337, P170202340, P170202341, P170202342, P170202343, P170202345, P170202346, P170202350, P170202353, P170202354, P170202355, P170202364, P170202365, P170202367, P170202370, P170202372, P170202376, P170202377, P170202381, P170202383, P170202384, P170202385, P170202387, P170202392, P170202395, P170202396, P170202398, P170202399, P170202402, P170202404, P170202405, P170202410, P170202413, P170202417, P170202419, P170202420, P170202421, P170202423, P170202426, P170202431, P170202433, P170202439, P170202441, P170202453, P170202458, P170202463, P170202465, P170202466, P170202470, P170202471, P170202472, P170202473, P170202476, P170202477, P170202481, P170202482, P170202484, P170202488, P170202490, P170202491, P170202492, P170202495, P170202501, P170202502, P170202506, P170202515, P170202526, P170202528, P170202529, P170202531, P170202532, P170202538, P170202544, P170202546, P170202550, P170202552, P170202554, P170202556, P170202557, P170202565, P170202569, P170202573, P170202574, P170202575, P170202579, P170202583, P170202585, P170202586, P170202589, P170202590, P170202591, P170202592, P170202593, P170202598, P170202606, P170202608, P170202611, P170202612, P170202613, P170202615, P170202616, P170202617, P170202618, P170202620, P170202623, P170202624, P170202625, P170202631, P170202632, P170202634, P170202635, P170202636, P170202639, P170202640, P170202642, P170202645, P170202647, P170202649, P170202656, P170202660, P170202670, P170202673, P170202674, P170202679, P170202680, P170202685, P170202690, P170202691, P170202701, P170202704, P170202710, P170202712, P170202720, P170202722, P170202723, P170202724, P170202728, P170202730, P170202732, P170202735, P170202739, P170202740, P170202742, P170202743, P170202746, P170202749, P170202752, P170202764, P170202766, P170202767, P170202768, P170202774, P170202775, P170202780, P170202781, P170202787, P170202793, P170202796, P170202803, P170202813, P170202816, P170202818, P170202820, P170202832, P170202833, P170202836, P170202840, P170202841, P170202846, P170202851, P170202855, P170202861, P170202865, P170202868, P170202870, P170202872, P170202873, P170202876, P170202877, P170202880, P170202883, P170202890, P170202892, P170202893, P170202894, P170202895, P170202897, P170202898, P170202900, P170202906, P170202907, P170202909, P170202910, P170202915, P170202916, P170202920, P170202921, P170202923, P170202924, P170202925, P170202926, P170202928, P170202941, P170202943, P170202945, P170202946, P170202950, P170202951, P170202959, P170202965, P170202967, P170202968, P170202970, P170202978, P170202979, P170202980, P170202981, P170202982, P170202983, P170202985, P170202991, P170202992, P170202993, P170202996, P170202998, P170203002, P170203003, P170203005, P170203006, P170203007, P170203008, P170203009, P170203013, P170203016, P170203017, P170203019, P170303022, P170303025, P170303037, P170303040, P170303041, P170303042, P170303043, P170303045, P170303051, P170303052, P170303053, P170303059, P170303060, P170303062, P170303063, P170303064, P170303066, P170303071, P170303073, P170303074, P170303076, P170303079, P170303080, P170303083, P170303084, P170303089, P170303091, P170303093, P170303094, P170303098, P170303101, P170303102, P170303103, P170303107, P170303108, P170303112, P170303117, P170303123, P170303124, P170303126, P170303128, P170303131, P170303132, P170303133, P170303134, P170303139, P170303140, P170303142, P170303146, P170303148, P170303151, P170303152, P170303158, P170303160, P170303161, P170303163, P170303164, P170303165, P170303166, P170303167, P170303176, P170303182, P170303184, P170303185, P170303187, P170303188, P170303190, P170303191, P170303194, P170303200, P170303201, P170303203, P170303207, P170303208, P170303209, P170303210, P170303212, P170303213, P170303214, P170303218, P170303220, P170303221, P170303224, P170303229, P170303230, P170303232, P170303234, P170303239, P170303241, P170303244, P170303246, P170303247, P170303248, P170303254, P170303256, P170303257, P170303264, P170303265, P170303267, P170303268, P170303270, P170303272, P170303276, P170303277, P170303279, P170303283, P170303284, P170303286, P170303290, P170303292, P170303294, P170303297, P170303299, P1703033...

Label field

Details supplied by the agency

Lot, code or applicability

Model Number CM1100; UDI/DI: 05414734509800; Serial Numbers: P150800220, P150800222, P150800226, P150800240, P150800242, P150800245, P150800246, P150800249, P150800262, P150800263, P150800264, P150800265, P150800266, P150800267, P150800268, P150800273, P150800277, P150900313, P150900315, P150900318, P150900319, P150900322, P150900333, P150900334, P150900335, P150900337, P150900343, P150900344, P150900349, P150900350, P160100406, P160100410, P160100412, P160100414, P160100416, P160100419, P160100422, P160200429, P160200434, P160200435, P160200440, P160200442, P160200451, P160200452, P160200453, P160200456, P160200459, P160200464, P160200466, P160200469, P160200476, P160200479, P160200480, P160200486, P160200487, P160200488, P160200489, P160200490, P160200493, P160200498, P160200505, P160200511, P160200512, P160200515, P160200518, P160200521, P160200524, P160200527, P160200528, P160200529, P160200530, P160200535, P160200538, P160200539, P160200540, P160200545, P160200548, P160200552, P160200557, P160200559, P160200565, P160200566, P160200568, P160200569, P160200571, P160200573, P160200575, P160500583, P160500596, P160500597, P160500601, P160500602, P160600606, P160600607, P160600608, P160600609, P160600610, P160600612, P160600621, P160600622, P160600625, P160600626, P160600632, P160600633, P160600636, P160600638, P160600643, P160600646, P160600647, P160600656, P160600658, P160600659, P160600663, P160600664, P160600668, P160600669, P160600676, P160600678, P160600681, P160600682, P160600684, P160600694, P160600695, P160600697, P160600699, P160600700, P160600706, P160600712, P160600714, P160600716, P160600717, P160600719, P160600723, P160600725, P160600727, P160600730, P160600731, P160600732, P160900733, P160900734, P160900736, P160900743, P160900746, P160900747, P160900748, P160900749, P160900750, P160900751, P160900752, P160900758, P160900759, P160900764, P160900765, P160900767, P160900774, P160900776, P160900777, P160900778, P160900779, P160900780, P160900781, P160900782, P160900786, P160900789, P160900792, P161000793, P161000795, P161000800, P161000804, P161000805, P161000806, P161000810, P161000811, P161000812, P161000819, P161000821, P161000828, P161000832, P161000844, P161000846, P161000847, P161000854, P161000855, P161000857, P161000861, P161000862, P161000864, P161000866, P161000884, P161000890, P161000899, P161000900, P161000901, P161000902, P161000906, P161000912, P161000914, P161000915, P161000917, P161000922, P161000926, P161000927, P161000928, P161000931, P161000936, P161000949, P161000954, P161000956, P161000959, P161000961, P161000962, P161000963, P161000965, P161000967, P161000968, P161000971, P161000973, P161000977, P161000978, P161000979, P161000981, P161000983, P161000984, P161000986, P161000988, P161000991, P161000994, P161000998, P161001003, P161001004, P161001007, P161001009, P161001010, P161001012, P161001014, P161001015, P161001017, P161001018, P161001024, P161001025, P161001026, P161001030, P161001032, P161001038, P161001041, P161001042, P161001044, P161001045, P161001046, P161001048, P161001051, P161001053, P161001054, P161001060, P161001062, P161001069, P161001076, P161001078, P161001079, P161001084, P161001085, P161001086, P161001087, P161001091, P161001094, P161001096, P161001098, P161001100, P161001101, P161001102, P161001104, P161001111, P161001112, P161001127, P161001128, P161001130, P161001133, P161001142, P161001147, P161001148, P161001150, P161001152, P161001153, P161001155, P161001157, P161001160, P161001163, P161001164, P161001165, P161001168, P161001169, P161001171, P161001177, P161001178, P161001179, P161001186, P161001187, P161001188, P161001190, P161001191, P161001193, P161001203, P161001204, P161001205, P161001208, P161101223, P161101224, P161101225, P161101236, P161101238, P161101240, P161101241, P161101242, P161101243, P161101244, P161101273, P161101277, P161101280, P161101281, P161101289, P161101290, P161101291, P161101296, P161101297, P161101302, P161101305, P161101312, P161101313, P161101314, P161101315, P161101317, P161101319, P161101321, P161101323, P161101324, P161101331, P161101332, P161101334, P161101339, P161101340, P161101341, P161101342, P161101343, P161101345, P161101348, P161101352, P161101357, P161101359, P161101361, P161101362, P161101363, P161101366, P161101369, P161101376, P161101377, P161101379, P161101382, P161101383, P161101388, P161101389, P161101390, P161101396, P161101397, P161101400, P161101403, P161101404, P161101405, P161101408, P161101410, P161101425, P161101429, P161101431, P161101434, P161101439, P161101440, P161101442, P161101444, P161101449, P161101450, P161101451, P161101452, P161101457, P161101465, P161101466, P161101469, P161101470, P161101471, P161101472, P161101474, P161101481, P161101487, P161101488, P161101490, P161101491, P161101492, P161101494, P161101499, P161101502, P161101504, P161101509, P161101510, P161101514, P161101520, P161101526, P161101527, P161101530, P161101531, P161101533, P161101541, P161101542, P161101551, P161101553, P161101554, P161101555, P161101557, P161101562, P161101564, P161101566, P161101570, P161101571, P161201573, P161201584, P161201586, P161201588, P161201589, P161201591, P161201594, P161201599, P161201605, P161201608, P161201609, P161201610, P161201617, P161201618, P161201622, P161201623, P161201625, P161201630, P161201634, P161201642, P161201643, P161201644, P161201645, P161201647, P161201650, P161201652, P161201653, P161201654, P161201656, P161201658, P161201660, P161201698, P161201699, P161201704, P161201705, P161201707, P161201708, P161201712, P161201718, P161201719, P161201720, P161201721, P161201722, P161201727, P161201733, P161201735, P161201736, P161201742, P161201744, P161201745, P161201747, P161201749, P161201750, P161201752, P161201758, P161201760, P161201761, P161201764, P161201765, P161201769, P161201770, P161201785, P161201788, P161201789, P161201790, P161201794, P170101817, P170101818, P170101822, P170101826, P170101828, P170101829, P170101835, P170101836, P170101837, P170101842, P170101843, P170101845, P170101850, P170101851, P170101852, P170101853, P170101855, P170101856, P170101857, P170101858, P170101866, P170101867, P170101869, P170101873, P170101874, P170101875, P170101876, P170101878, P170101883, P170101884, P170101885, P170101886, P170101889, P170101891, P170101894, P170101897, P170101898, P170101916, P170101918, P170101921, P170101931, P170101933, P170101935, P170101954, P170101955, P170101957, P170101959, P170101963, P170101967, P170101977, P170101978, P170101980, P170101984, P170101990, P170101992, P170101993, P170101994, P170101995, P170101998, P170101999, P170102000, P170102005, P170102011, P170102015, P170102017, P170102019, P170102020, P170102029, P170102031, P170102032, P170102038, P170102042, P170102045, P170102048, P170102049, P170102052, P170102053, P170102055, P170102058, P170102060, P170102062, P170102067, P170102068, P170102070, P170102081, P170102085, P170102086, P170102090, P170102091, P170102092, P170102093, P170102097, P170102103, P170102105, P170102106, P170102110, P170102112, P170102114, P170102115, P170102121, P170102122, P170102128, P170102129, P170102130, P170102134, P170102136, P170102144, P170102152, P170102153, P170102164, P170102170, P170102171, P170102175, P170102199, P170102201, P170102206, P170102209, P170102210, P170102212, P170102214, P170102218, P170102224, P170102226, P170102229, P170102232, P170102237, P170102243, P170102245, P170102247, P170102259, P170102261, P170102263, P170102264, P170102272, P170102273, P170102278, P170102281, P170102284, P170102289, P170102290, P170102291, P170102298, P170202302, P170202306, P170202309, P170202310, P170202311, P170202312, P170202315, P170202318, P170202320, P170202325, P170202328, P170202330, P170202331, P170202332, P170202333, P170202335, P170202336, P170202337, P170202340, P170202341, P170202342, P170202343, P170202345, P170202346, P170202350, P170202353, P170202354, P170202355, P170202364, P170202365, P170202367, P170202370, P170202372, P170202376, P170202377, P170202381, P170202383, P170202384, P170202385, P170202387, P170202392, P170202395, P170202396, P170202398, P170202399, P170202402, P170202404, P170202405, P170202410, P170202413, P170202417, P170202419, P170202420, P170202421, P170202423, P170202426, P170202431, P170202433, P170202439, P170202441, P170202453, P170202458, P170202463, P170202465, P170202466, P170202470, P170202471, P170202472, P170202473, P170202476, P170202477, P170202481, P170202482, P170202484, P170202488, P170202490, P170202491, P170202492, P170202495, P170202501, P170202502, P170202506, P170202515, P170202526, P170202528, P170202529, P170202531, P170202532, P170202538, P170202544, P170202546, P170202550, P170202552, P170202554, P170202556, P170202557, P170202565, P170202569, P170202573, P170202574, P170202575, P170202579, P170202583, P170202585, P170202586, P170202589, P170202590, P170202591, P170202592, P170202593, P170202598, P170202606, P170202608, P170202611, P170202612, P170202613, P170202615, P170202616, P170202617, P170202618, P170202620, P170202623, P170202624, P170202625, P170202631, P170202632, P170202634, P170202635, P170202636, P170202639, P170202640, P170202642, P170202645, P170202647, P170202649, P170202656, P170202660, P170202670, P170202673, P170202674, P170202679, P170202680, P170202685, P170202690, P170202691, P170202701, P170202704, P170202710, P170202712, P170202720, P170202722, P170202723, P170202724, P170202728, P170202730, P170202732, P170202735, P170202739, P170202740, P170202742, P170202743, P170202746, P170202749, P170202752, P170202764, P170202766, P170202767, P170202768, P170202774, P170202775, P170202780, P170202781, P170202787, P170202793, P170202796, P170202803, P170202813, P170202816, P170202818, P170202820, P170202832, P170202833, P170202836, P170202840, P170202841, P170202846, P170202851, P170202855, P170202861, P170202865, P170202868, P170202870, P170202872, P170202873, P170202876, P170202877, P170202880, P170202883, P170202890, P170202892, P170202893, P170202894, P170202895, P170202897, P170202898, P170202900, P170202906, P170202907, P170202909, P170202910, P170202915, P170202916, P170202920, P170202921, P170202923, P170202924, P170202925, P170202926, P170202928, P170202941, P170202943, P170202945, P170202946, P170202950, P170202951, P170202959, P170202965, P170202967, P170202968, P170202970, P170202978, P170202979, P170202980, P170202981, P170202982, P170202983, P170202985, P170202991, P170202992, P170202993, P170202996, P170202998, P170203002, P170203003, P170203005, P170203006, P170203007, P170203008, P170203009, P170203013, P170203016, P170203017, P170203019, P170303022, P170303025, P170303037, P170303040, P170303041, P170303042, P170303043, P170303045, P170303051, P170303052, P170303053, P170303059, P170303060, P170303062, P170303063, P170303064, P170303066, P170303071, P170303073, P170303074, P170303076, P170303079, P170303080, P170303083, P170303084, P170303089, P170303091, P170303093, P170303094, P170303098, P170303101, P170303102, P170303103, P170303107, P170303108, P170303112, P170303117, P170303123, P170303124, P170303126, P170303128, P170303131, P170303132, P170303133, P170303134, P170303139, P170303140, P170303142, P170303146, P170303148, P170303151, P170303152, P170303158, P170303160, P170303161, P170303163, P170303164, P170303165, P170303166, P170303167, P170303176, P170303182, P170303184, P170303185, P170303187, P170303188, P170303190, P170303191, P170303194, P170303200, P170303201, P170303203, P170303207, P170303208, P170303209, P170303210, P170303212, P170303213, P170303214, P170303218, P170303220, P170303221, P170303224, P170303229, P170303230, P170303232, P170303234, P170303239, P170303241, P170303244, P170303246, P170303247, P170303248, P170303254, P170303256, P170303257, P170303264, P170303265, P170303267, P170303268, P170303270, P170303272, P170303276, P170303277, P170303279, P170303283, P170303284, P170303286, P170303290, P170303292, P170303294, P170303297, P170303299, P1703033...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, KUWAIT, NETHERLANDS, PORTUGAL, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Nov 15, 2023
Recall initiation date: Oct 4, 2023
Center classification date: Nov 3, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records