CLASS II Device recall · Reported 4 Jul 2012 · FDA Enforcement Report

Stryker MA204 Bed recalled by Stryker Medical Division of

Stryker Medical Division of Stryker is recalling Stryker MA204 Bed, distributed nationwide in the US. The recall was initiated on 17 May 2012 and the FDA has classified it as Class II.

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K02006, K02005, K02004, K02003, K02002, K02001, K02000, K01999, K01998, K01997, K01996, K01995, K01994, K01993, K01992, K01991, K01990, K01989, K01988, K01987, K01986, K01985, K01984, K01983, K01982, K01981, K01980, K01979, K01973, K01937, K01936, K01935, K01934, K01933, K01931, K01930, K01929, K01928, K01927, K01926, K01925, K01924, K01923, K01922, K01921, K01920, K01919, K01918, K01917, K01916, K01915, K01914, K01913, K01912, K01911, K01910, K01909, K01908, K01907, K01906, K01905, K01904, K01903, K01902, K01901, K01900, K01899, K01898, K01897, K01896, K01895, K01894, K01893, K01892, K01859, K01858, K01857, K01856, K01855, K01854, K01853, K01852, K01814, K01813, K01812, K01811, K01810, K01809, K01808, K01807, K01806, K01805, K01804, K01803, K01802, K01801, K01800, K01799, K01798, K01797, K01796, K01795, K01794, K01793, K01792, K01791, K01790, K01789, K01788, K01787, K01786, K01785, K01784, K01783, K01782, K01781, K01780, K01779, K01778, K01777, K01776, K01775, K01774, K01773, K01772, K01771, K01770, K01769, K01768, K01767, K01766, K01765, K01738, K01737, K01736, K01735, K01734, K01709, K01708, K01707, K01706, K01705, K01704, K01703, K01702, K01701, K01700, K01699, K01698, K01697, K01696, K01695, K01694, K01693, K01692, K01691, K01690, K01689, K01688, K01687, K01686, K01685, K01684, K01683, K01682, K01681, K01680, K01679, K01678, K01677, K01676, K01675, K01674, K01673, K01672, K01671, K01670, K01669, K01668, K01667, K01666, K01665, K01664, K01663, K01662, K01661, K01660, K01659, K01658, K01657, K01656, K01655, K01654, K01653, K01652, K01651, K01650, K01649, K01648, K01647, K01646, K01645, K01644, K01643, K01642, K01641, K01640, K01639, K01638, K01613, K01612, K01611, K01610, K01609, K01608, K01607, K01606, K01605, K01604, K01603, K01601, K01600, K01599, K01598, K01597, K01596, K01595, K01594, K01593, K01592, K01591, K01590, K01589, K01588, K01587, K01586, K01585, K01584, K01583, K01582, K01581, K01580, K01579, K01578, K01577, K01576, K01575, K01574, K01573, K01572, K01571, K01570, K01569, K01568, K01567, K01566, K01565, K01564, K01563, K01531, K01530, K01529, K01528, K01527, K01526, K01525, K01524, K01523, K01522, K01521, K01520, K01519, K01518, K01517, K01516, K01515, K01514, K01513, K01512, K01511, K01510, K01509, K01508, K01507, K01506, K01505, K01504, K01503, K01502, K01501, K01500, K01499, K01498, K01497, K01496, K01495, K01494, K01493, K01492, K01491, K01490, K01486, K01485, K01484, K01483, K01482, K01481, K01480, K01479, K01478, K01477, K01476, K01475, K01474, K01473, K01472, K01471, K01470, K01469, K01468, K01467, K01466, K01465, K01464, K01463, K01462, K01461, K01460, K01459, K01458, K01457, K01456, K01455, K01454, K01453, K01452, K01451, K01450, K01449, K01448, K01447, K01445, K01443, K01442, K01441, K01440, K01439, K01438, K01437, K01436, K01435, K01434, K01433, K01432, K01431, K01430, K01429, K01428, K01427, K01426, K01425, K01424, K01423, K01422, K01421, K01420, K01419, K01418, K01417, K01416, K01415, K01414, K01413, K01412, K01411, K01410, K01409, K01408, K01407, K01406, K01405, K01404, K01403, K01402, K01401, K01400, K01399, K01398, K01397, K01396, K01395, K01394, K01393, K01392, K01391, K01390, K01389, K01388, K01387, K01385, K01384, K01383, K01382, K01381, K01380, K01379, K01378, K01377, K01376, K01375, K01374, K01373, K01372, K01371, K01370, K01369, K01368, K01367, K01366, K01365, K01364, K01363, K01362, K01361, K01360, K01359, K01358, K01357, K01356, K01355, K01354, K01353, K01352, K01351, K01350, K01349, K01348, K01347, K01346, K01345, K01344, K01343, K01342, K01341, K01340, K01339, K01338, K01337, K01336, K01335, K01334, K01333, K01332, K01331, K01330, K01329, K01328, K01327, K01326, K01325, K01324, K01323, K01322, K01321, K01320, K01318, K01317, K01316, K01315, K01314, K01313, K01312, K01311, K01310, K01309, K01308, K01307, K01306, K01305, K01304, K01303, K01302, K01301, K01300, K01299, K01298, K01297, K01296, K01295, K01294, K01293, K01292, K01291, K01290, K01289, K01288, K01287, K01286, K01285, K01284, K01283, K01282, K01281, K01280, K01279, K01278, K01277, K01276, K01275, K01274, K01273, K01272, K01271, K01270, K01269, K01268, K01267, K01266, K01265, K01264, K01263, K01262, K01261, K01260, K01259, K01258, K01257, K01256, K01255, K01254, K01253, K01252, K01251, K01250, K01249, K01248, K01247, K01246, K01245, K01244, K01243, K01242, K01241, K01240, K01239, K01238, K01237, K01236, K01235, K01234, K01233, K01232, K01231, K01230, K01229, K01228, K01227, K01226, K01225, K01224, K01223, K01222, K01221, K01220, K01219, K01218, K01217, K01216, K01215, K01214, K01213, K01212, K01211, K01210, K01209, K01208, K01207, K01206, K01205, K01204, K01203, K01201, K01197, K01196, K01195, K01194, K01193, K01192, K01191, K01190, K01189, K01188, K01187, K01186, K01185, K01184, K01183, K01182, K01181, K01180, K01179, K01178, K01177, K01176, K01175, K01174, K01173, K01172, K01171, K01170, K01169, K01168, K01167, K01166, K01165, K01164, K01163, K01162, K01161, K01160, K01159, K01158, K01157, K01156, K01155, K01154, K01153, K01152, K01151, K01150, K01149, K01148, K01147, K01146, K01145, K01144, K01143, K01142, K01141, K01140, K01139, K01138, K01137, K01136, K01135, K01134, K01133, K01132, K01131, K01130, K01129, K01128, K01127, K01126, K01125, K01124, K01123, K01122, K01121, K01120, K01119, K01118, K01117, K01116, K01115, K01114, K01113, K01112, K01111, K01110, K01109, K01108, K01107, K01106, K01105, K01104, K01103, K01102, K01101, K01100, K01099, K01098, K01097, K01096, K01095, K01094, K01093, K01092, K01091, K01090, K01089, K01088, K01087, K01086, K01085, K01084, K01083, K01082, K01081, K01080, K01079, K01078, K01077, K01076, K01075, K01074, K01073, K01072, K01071, K01070, K01069, K01068, K01067, K01066, K01065, K01064, K01063, K01062, K01061, K01060, K01059, K01058, K01057, K01056, K01055, K01054, K01053, K01052, K01051, K01050, K01049, K01048, K01047, K01046, K01045, K01044, K01043, K01042, K01041, K01040, K01039, K01038, K01037, K01036, K01035, K01034, K01033, K01032, K01031, K01030, K01029, K01028, K01027, K01026, K01025, K01024, K01022, K01021, K01020, K01019, K01018, K01017, K01016, K01013, K00064, K00063, K00062, K00061, K00060, K00058, K00056, K00055, K00054, K00053, K00052, K00051, K00050, K00049, K00048, K00047, K00046, K00045, K00044, K00043, K00042, K00041, K00040, K00039, K00038, K00037, K00036, K00035, K00034, K00033, K00032, K00031, K00030, K00029, K00005, K00004, and K00000.

Quantity recalled2546

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-1862-2012
FDA event ID: 61712
Recalling firm: Stryker Medical Division of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 17 May 2012
FDA classified: 22 Jun 2012
Reported: 4 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

17 May 2012	Recall initiated by company
22 Jun 2012	Classified by FDA	+36 days
4 Jul 2012	Published in enforcement report	+12 days

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

Reason for recall

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

Where it was distributed

Worldwide distribution:USA (nationwide) and countries including: Argentina, Bertec, Brasil, Brazil, Canada, Chile, China, India, Latin America, Mexico,Osteonics SA, Polska, Portugal, Puerto Rico, and Singapore.

Nationwide Puerto Rico

Questions about this recall

Is Stryker MA204 Bed recalled?

Yes. Stryker Medical Division of Stryker recalled Stryker MA204 Bed on 17 May 2012. The recall is Class II and its status is Terminated. Recall number Z-1862-2012.

Why was it recalled?

Which lots are affected?

Model FL25E: QK02276, QK02274, QK01602, KK01602, K03922, K03921, K03920, K03919, K03918, K03917, K03916, K03915, K03914, K03913, K03912, K03911, K03910, K03909, K03908, K03907, K03906, K03905, K03904, K03903, K03902, K03901, K03900, K03899, K03898, K03897, K03896, K03895, K03894, K03893, K03892, K03891, K03890, K03889, K03888, K03887, K03886, K03885, K03884, K03883, K03882, K03881, K03880, K03879, K03878, K03877, K03876, K03875, K03874, K03873, K03872, K03871, K03870, K03869, K03868, K03867, K03866, K03865, K03864, K03863, K03862, K03861, K03860, K03859, K03858, K03857, K03856, K03855, K03854, K03853, K03852, K03851, K03850, K03849, K03848, K03847, K03846, K03845, K03844, K03843, K03842, K03841, K03840, K03839, K03838, K03837, K03836, K03835, K03834, K03833, K03832, K03831, K03830, K03829, K03828, K03827, K03826, K03825, K03824, K03823, K03822, K03821, K03820, K03819, K03818, K03817, K03816, K03815, K03814, K03813, K03812, K03811, K03810, K03809, K03808, K03807, K03806, K03805, K03804, K03803, K03802, K03801, K03800, K03799, K03798, K03797, K03796, K03795, K03794, K03793, K03792, K03791, K03790, K03789, K03788, K03787, K03786, K03785, K03784, K03783, K03782, K03781, K03780, K03779, K03778, K03777, K03776, K03775, K03774, K03773, K03772, K03771, K03770, K03769, K03768, K03767, K03766, K03765, K03764, K03763, K03762, K03761, K03760, K03759, K03758, K03757, K03756, K03755, K03754, K03753, K03752, K03751, K03750, K03749, K03748, K03747, K03746, K03745, K03744, K03743, K03742, K03741, K03740, K03739, K03738, K03737, K03736, K03735, K03734, K03733, K03732, K03731, K03730, K03729, K03728, K03727, K03726, K03725, K03724, K03723, K03722, K03721, K03720, K03719, K03718, K03717, K03716, K03715, K03714, K03713, K03712, K03711, K03710, K03709, K03708, K03707, K03706, K03705, K03704, K03703, K03702, K03701, K03700, K03699, K03698, K03697, K03696, K03695, K03694, K03693, K03692, K03691, K03690, K03689, K03688, K03687, K03686, K03685, K03684, K03683, K03682, K03681, K03680, K03679, K03678, K03677, K03676, K03675, K03674, K03673, K03672, K03671, K03670, K03669, K03668, K03667, K03666, K03665, K03664, K03663, K03662, K03661, K03660, K03659, K03658, K03657, K03656, K03655, K03654, K03653, K03652, K03651, K03650, K03649, K03648, K03647, K03646, K03645, K03644, K03643, K03642, K03641, K03640, K03639, K03638, K03637, K03636, K03635, K03634, K03633, K03632, K03631, K03630, K03629, K03628, K03627, K03626, K03625, K03624, K03623, K03622, K03621, K03620, K03619, K03618, K03617, K03616, K03615, K03614, K03613, K03612, K03611, K03610, K03609, K03608, K03607, K03606, K03605, K03604, K03603, K03602, K03601, K03600, K03599, K03598, K03597, K03596, K03595, K03594, K03593, K03592, K03591, K03590, K03589, K03588, K03587, K03586, K03585, K03584, K03583, K03582, K03581, K03580, K03579, K03578, K03577, K03576, K03575, K03574, K03573, K03572, K03571, K03570, K03569, K03568, K03567, K03566, K03565, K03564, K03563, K03562, K03561, K03560, K03559, K03558, K03557, K03556, K03555, K03554, K03553, K03552, K03551, K03550, K03549, K03548, K03547, K03546, K03545, K03544, K03543, K03542, K03541, K03540, K03539, K03538, K03537, K03536, K03535, K03534, K03533, K03532, K03531, K03530, K03529, K03528, K03527, K03526, K03525, K03524, K03523, K03522, K03521, K03520, K03519, K03518, K03517, K03516, K03515, K03514, K03513, K03512, K03511, K03510, K03509, K03508, K03507, K03506, K03505, K03504, K03503, K03502, K03501, K03500, K03499, K03498, K03497, K03496, K03495, K03494, K03493, K03492, K03491, K03490, K03489, K03488, K03487, K03486, K03485, K03484, K03483, K03482, K03481, K03480, K03479, K03478, K03477, K03476, K03475, K03474, K03473, K03472, K03471, K03470, K03469, K03468, K03467, K03466, K03465, K03464, K03463, K03462, K03461, K03460, K03459, K03458, K03457, K03456, K03455, K03454, K03453, K03452, K03451, K03450, K03449, K03448, K03447, K03446, K03445, K03444, K03443, K03442, K03441, K03440, K03439, K03438, K03437, K03436, K03435, K03434, K03433, K03432, K03431, K03430, K03429, K03428, K03427, K03426, K03425, K03424, K03423, K03422, K03421, K03420, K03419, K03418, K03417, K03416, K03415, K03414, K03413, K03412, K03411, K03410, K03409, K03408, K03407, K03406, K03405, K03404, K03403, K03402, K03401, K03400, K03399, K03398, K03397, K03396, K03395, K03394, K03393, K03392, K03391, K03390, K03389, K03388, K03387, K03386, K03385, K03384, K03383, K03382, K03381, K03380, K03379, K03378, K03377, K03376, K03375, K03374, K03373, K03372, K03371, K03370, K03369, K03368, K03367, K03366, K03365, K03364, K03363, K03362, K03361, K03360, K03359, K03358, K03357, K03356, K03355, K03354, K03353, K03352, K03351, K03350, K03349, K03348, K03347, K03346, K03345, K03344, K03343, K03342, K03341, K03340, K03339, K03338, K03337, K03336, K03335, K03334, K03333, K03332, K03331, K03330, K03329, K03328, K03327, K03326, K03325, K03324, K03323, K03322, K03321, K03320, K03319, K03318, K03317, K03316, K03315, K03314, K03313, K03312, K03311, K03310, K03309, K03308, K03307, K03306, K03305, K03304, K03303, K03302, K03301, K03300, K03299, K03298, K03297, K03296, K03295, K03294, K03293, K03292, K03291, K03290, K03289, K03288, K03287, K03286, K03285, K03284, K03283, K03282, K03281, K03280, K03279, K03278, K03277, K03276, K03275, K03274, K03273, K03272, K03271, K03270, K03269, K03268, K03267, K03266, K03265, K03264, K03263, K03262, K03261, K03260, K03259, K03258, K03257, K03256, K03255, K03254, K03253, K03252, K03251, K03250, K03249, K03248, K03247, K03246, K03245, K03244, K03243, K03242, K03241, K03240, K03239, K03238, K03237, K03236, K03235, K03234, K03233, K03232, K03231, K03230, K03229, K03228, K03227, K03226, K03225, K03224, K03223, K03222, K03221, K03220, K03219, K03218, K03217, K03216, K03215, K03214, K03213, K03212, K03211, K03210, K03209, K03208, K03207, K03206, K03205, K03204, K03203, K03202, K03201, K03200, K03199, K03198, K03197, K03196, K03195, K03194, K03193, K03192, K03191, K03190, K03189, K03188, K03187, K03186, K03185, K03184, K03183, K03182, K03181, K03180, K03179, K03178, K03177, K03176, K03175, K03174, K03173, K03172, K03171, K03170, K03169, K03168, K03167, K03166, K03165, K03164, K03163, K03162, K03161, K03160, K03159, K03158, K03157, K03156, K03155, K03154, K03153, K03152, K03151, K03150, K03149, K03148, K03147, K03146, K03145, K03144, K03143, K03142, K03141, K03140, K03139, K03138, K03137, K03136, K03135, K03134, K03133, K03132, K03131, K03130, K03129, K03128, K03127, K03126, K03125, K03124, K03123, K03122, K03121, K03120, K03119, K03118, K03117, K03116, K03115, K03114, K03113, K03112, K03111, K03110, K03109, K03108, K03107, K03106, K03105, K03104, K03103, K03102, K03101, K03100, K03099, K03098, K03097, K03096, K03095, K03094, K03093, K03092, K03091, K03090, K03089, K03088, K03087, K03086, K03085, K03084, K03083, K03082, K03081, K03080, K03079, K03078, K03077, K03076, K03075, K03074, K03073, K03072, K03071, K03070, K03069, K03068, K03067, K03066, K03065, K03064, K03063, K03062, K03061, K03060, K03059, K03058, K03057, K03056, K03055, K03054, K03053, K03052, K03051, K03050, K03049, K03048, K03047, K03046, K03045, K03044, K03043, K03042, K03041, K03040, K03039, K03038, K03037, K03036, K03035, K03034, K03033, K03032, K03031, K03030, K03029, K03028, K03027, K03026, K03025, K03024, K03023, K03022, K03021, K03020, K03019, K03018, K03017, K03016, K03015, K03014, K03013, K03012, K03011, K03010, K03009, K03008, K03007, K03006, K03005, K03004, K03003, K03002, K03001, K03000, K02999, K02998, K02997, K02996, K02995, K02994, K02993, K02992, K02991, K02990, K02989, K02988, K02987, K02986, K02985, K02984, K02983, K02982, K02981, K02980, K02979, K02978, K02977, K02976, K02975, K02974, K02973, K02972, K02971, K02970, K02969, K02968, K02967, K02966, K02965, K02964, K02963, K02962, K02961, K02960, K02959, K02958, K02957, K02956, K02955, K02954, K02953, K02952, K02951, K02950, K02949, K02948, K02947, K02946, K02945, K02944, K02943, K02942, K02941, K02940, K02939, K02938, K02937, K02936, K02935, K02934, K02933, K02932, K02931, K02930, K02929, K02928, K02927, K02926, K02925, K02924, K02923, K02922, K02921, K02920, K02919, K02918, K02917, K02916, K02915, K02914, K02913, K02912, K02911, K02910, K02909, K02908, K02907, K02906, K02905, K02904, K02903, K02902, K02901, K02900, K02899, K02898, K02897, K02896, K02895, K02894, K02893, K02892, K02891, K02890, K02889, K02888, K02887, K02886, K02885, K02884, K02883, K02882, K02881, K02880, K02879, K02878, K02877, K02876, K02875, K02874, K02873, K02872, K02871, K02870, K02869, K02868, K02867, K02866, K02865, K02864, K02863, K02862, K02861, K02860, K02859, K02858, K02857, K02856, K02855, K02854, K02853, K02852, K02851, K02850, K02849, K02848, K02847, K02846, K02845, K02844, K02843, K02842, K02841, K02840, K02839, K02838, K02837, K02836, K02835, K02834, K02833, K02832, K02831, K02830, K02829, K02828, K02827, K02826, K02825, K02824, K02823, K02822, K02821, K02820, K02819, K02818, K02817, K02816, K02815, K02814, K02813, K02812, K02811, K02810, K02809, K02808, K02807, K02806, K02805, K02804, K02803, K02802, K02801, K02800, K02799, K02798, K02797, K02796, K02795, K02794, K02793, K02792, K02791, K02790, K02789, K02788, K02787, K02786, K02785, K02784, K02783, K02782, K02781, K02780, K02779, K02778, K02777, K02776, K02775, K02774, K02773, K02772, K02771, K02770, K02769, K02768, K02767, K02766, K02765, K02764, K02763, K02762, K02761, K02760, K02759, K02758, K02757, K02756, K02755, K02754, K02753, K02752, K02751, K02750, K02749, K02748, K02747, K02746, K02745, K02744, K02743, K02742, K02741, K02740, K02739, K02738, K02737, K02736, K02735, K02734, K02733, K02732, K02731, K02730, K02729, K02728, K02727, K02726, K02725, K02724, K02723, K02722, K02721, K02720, K02719, K02718, K02717, K02716, K02715, K02714, K02713, K02712, K02711, K02710, K02709, K02708, K02707, K02706, K02705, K02704, K02703, K02702, K02701, K02700, K02699, K02698, K02697, K02696, K02695, K02694, K02693, K02692, K02691, K02690, K02689, K02688, K02687, K02686, K02685, K02684, K02683, K02682, K02681, K02680, K02679, K02678, K02677, K02676, K02675, K02674, K02673, K02672, K02671, K02670, K02669, K02668, K02667, K02666, K02665, K02664, K02663, K02662, K02661, K02660, K02659, K02658, K02657, K02656, K02655, K02654, K02653, K02652, K02651, K02650, K02649, K02648, K02647, K02646, K02645, K02644, K02643, K02642, K02641, K02640, K02639, K02638, K02637, K02636, K02635, K02634, K02633, K02632, K02631, K02630, K02629, K02628, K02627, K02626, K02625, K02624, K02623, K02622, K02621, K02620, K02619, K02618, K02617, K02616, K02615, K02614, K02613, K02612, K02611, K02610, K02609, K02608, K02607, K02606, K02605, K02604, K02603, K02602, K02601, K02600, K02599, K02598, K02597, K02596, K02595, K02594, K02593, K02592, K02591, K02590, K02589, K02588, K02587, K02586, K02585, K02584, K02583, K02582, K02581, K02580, K02579, K02578, K02577, K02576, K02575, K02574, K02573, K02572, K02571, K02570, K02569, K02568, K02567, K02566, K02565, K02564, K02563, K02562, K02561, K02560, K02559, K02558, K02557, K02556, K02555, K02554, K02553, K02552, K02551, K02550, K02549, K02548, K02547, K02546, K02545, K02544, K02543, K02542, K02541, K02540, K02539, K02538, K02537, K02536, K02535, K02534, K02533, K02532, K02531, K02530, K02529, K02528, K02527, K02526, K02525, K02524, K02523, K02522, K02521, K02520, K02519, K02518, K02517, K02516, K02515, K02514, K02513, K02512, K02511, K02510, K02509, K02508, K02507, K02506, K02505, K02504, K02503, K02502, K02501, K02500, K02499, K02498, K02497, K02496, K02495, K02494, K02493, K02492, K02491, K02490, K02489, K02488, K02487, K02486, K02485, K02484, K02483, K02482, K02481, K02480, K02479, K02478, K02477, K02476, K02475, K02474, K02473, K02472, K02471, K02470, K02469, K02468, K02467, K02466, K02465, K02464, K02463, K02462, K02461, K02460, K02459, K02458, K02457, K02456, K02455, K02454, K02453, K02452, K02451, K02450, K02449, K02448, K02447, K02446, K02445, K02444, K02443, K02442, K02441, K02440, K02439, K02438, K02437, K02436, K02433, K02432, K02431, K02430, K02429, K02428, K02427, K02426, K02425, K02424, K02423, K02422, K02421, K02420, K02419, K02418, K02417, K02416, K02415, K02414, K02413, K02412, K02411, K02410, K02409, K02408, K02407, K02406, K02405, K02403, K02402, K02401, K02400, K02399, K02398, K02397, K02396, K02395, K02394, K02393, K02392, K02391, K02390, K02389, K02388, K02387, K02386, K02385, K02384, K02383, K02382, K02381, K02380, K02379, K02378, K02377, K02376, K02375, K02374, K02373, K02372, K02371, K02370, K02369, K02368, K02367, K02366, K02365, K02364, K02330, K02329, K02328, K02327, K02326, K02325, K02323, K02322, K02321, K02320, K02319, K02318, K02317, K02316, K02315, K02313, K02312, K02311, K02309, K02308, K02307, K02306, K02305, K02304, K02303, K02302, K02301, K02300, K02299, K02298, K02297, K02296, K02295, K02294, K02292, K02290, K02289, K02288, K02287, K02286, K02285, K02284, K02282, K02281, K02279, K02277, K02275, K02273, K02272, K02271, K02270, K02269, K02268, K02267, K02266, K02265, K02264, K02263, K02262, K02261, K02260, K02259, K02258, K02257, K02256, K02255, K02254, K02253, K02252, K02251, K02250, K02249, K02222, K02221, K02220, K02219, K02218, K02217, K02216, K02215, K02214, K02213, K02212, K02211, K02210, K02209, K02208, K02207, K02206, K02205, K02204, K02203, K02202, K02201, K02200, K02199, K02198, K02197, K02196, K02195, K02194, K02193, K02192, K02191, K02190, K02188, K02187, K02186, K02185, K02184, K02183, K02182, K02181, K02180, K02179, K02178, K02177, K02176, K02175, K02174, K02173, K02172, K02171, K02170, K02169, K02168, K02167, K02166, K02165, K02164, K02163, K02162, K02161, K02160, K02159, K02158, K02157, K02156, K02155, K02154, K02153, K02152, K02151, K02150, K02149, K02148, K02147, K02146, K02145, K02144, K02143, K02142, K02141, K02140, K02139, K02138, K02137, K02136, K02135, K02134, K02133, K02132, K02131, K02130, K02129, K02128, K02127, K02126, K02125, K02124, K02123, K02122, K02121, K02120, K02119, K02118, K02117, K02116, K02115, K02114, K02011, K02010, K02009, K02008, K02007, K02006, K02005, K02004, K02003, K02002, K02001, K02000, K01999, K01998, K01997, K01996, K01995, K01994, K01993, K01992, K01991, K01990, K01989, K01988, K01987, K01986, K01985, K01984, K01983, K01982, K01981, K01980, K01979, K01973, K01937, K01936, K01935, K01934, K01933, K01931, K01930, K01929, K01928, K01927, K01926, K01925, K01924, K01923, K01922, K01921, K01920, K01919, K01918, K01917, K01916, K01915, K01914, K01913, K01912, K01911, K01910, K01909, K01908, K01907, K01906, K01905, K01904, K01903, K01902, K01901, K01900, K01899, K01898, K01897, K01896, K01895, K01894, K01893, K01892, K01859, K01858, K01857, K01856, K01855, K01854, K01853, K01852, K01814, K01813, K01812, K01811, K01810, K01809, K01808, K01807, K01806, K01805, K01804, K01803, K01802, K01801, K01800, K01799, K01798, K01797, K01796, K01795, K01794, K01793, K01792, K01791, K01790, K01789, K01788, K01787, K01786, K01785, K01784, K01783, K01782, K01781, K01780, K01779, K01778, K01777, K01776, K01775, K01774, K01773, K01772, K01771, K01770, K01769, K01768, K01767, K01766, K01765, K01738, K01737, K01736, K01735, K01734, K01709, K01708, K01707, K01706, K01705, K01704, K01703, K01702, K01701, K01700, K01699, K01698, K01697, K01696, K01695, K01694, K01693, K01692, K01691, K01690, K01689, K01688, K01687, K01686, K01685, K01684, K01683, K01682, K01681, K01680, K01679, K01678, K01677, K01676, K01675, K01674, K01673, K01672, K01671, K01670, K01669, K01668, K01667, K01666, K01665, K01664, K01663, K01662, K01661, K01660, K01659, K01658, K01657, K01656, K01655, K01654, K01653, K01652, K01651, K01650, K01649, K01648, K01647, K01646, K01645, K01644, K01643, K01642, K01641, K01640, K01639, K01638, K01613, K01612, K01611, K01610, K01609, K01608, K01607, K01606, K01605, K01604, K01603, K01601, K01600, K01599, K01598, K01597, K01596, K01595, K01594, K01593, K01592, K01591, K01590, K01589, K01588, K01587, K01586, K01585, K01584, K01583, K01582, K01581, K01580, K01579, K01578, K01577, K01576, K01575, K01574, K01573, K01572, K01571, K01570, K01569, K01568, K01567, K01566, K01565, K01564, K01563, K01531, K01530, K01529, K01528, K01527, K01526, K01525, K01524, K01523, K01522, K01521, K01520, K01519, K01518, K01517, K01516, K01515, K01514, K01513, K01512, K01511, K01510, K01509, K01508, K01507, K01506, K01505, K01504, K01503, K01502, K01501, K01500, K01499, K01498, K01497, K01496, K01495, K01494, K01493, K01492, K01491, K01490, K01486, K01485, K01484, K01483, K01482, K01481, K01480, K01479, K01478, K01477, K01476, K01475, K01474, K01473, K01472, K01471, K01470, K01469, K01468, K01467, K01466, K01465, K01464, K01463, K01462, K01461, K01460, K01459, K01458, K01457, K01456, K01455, K01454, K01453, K01452, K01451, K01450, K01449, K01448, K01447, K01445, K01443, K01442, K01441, K01440, K01439, K01438, K01437, K01436, K01435, K01434, K01433, K01432, K01431, K01430, K01429, K01428, K01427, K01426, K01425, K01424, K01423, K01422, K01421, K01420, K01419, K01418, K01417, K01416, K01415, K01414, K01413, K01412, K01411, K01410, K01409, K01408, K01407, K01406, K01405, K01404, K01403, K01402, K01401, K01400, K01399, K01398, K01397, K01396, K01395, K01394, K01393, K01392, K01391, K01390, K01389, K01388, K01387, K01385, K01384, K01383, K01382, K01381, K01380, K01379, K01378, K01377, K01376, K01375, K01374, K01373, K01372, K01371, K01370, K01369, K01368, K01367, K01366, K01365, K01364, K01363, K01362, K01361, K01360, K01359, K01358, K01357, K01356, K01355, K01354, K01353, K01352, K01351, K01350, K01349, K01348, K01347, K01346, K01345, K01344, K01343, K01342, K01341, K01340, K01339, K01338, K01337, K01336, K01335, K01334, K01333, K01332, K01331, K01330, K01329, K01328, K01327, K01326, K01325, K01324, K01323, K01322, K01321, K01320, K01318, K01317, K01316, K01315, K01314, K01313, K01312, K01311, K01310, K01309, K01308, K01307, K01306, K01305, K01304, K01303, K01302, K01301, K01300, K01299, K01298, K01297, K01296, K01295, K01294, K01293, K01292, K01291, K01290, K01289, K01288, K01287, K01286, K01285, K01284, K01283, K01282, K01281, K01280, K01279, K01278, K01277, K01276, K01275, K01274, K01273, K01272, K01271, K01270, K01269, K01268, K01267, K01266, K01265, K01264, K01263, K01262, K01261, K01260, K01259, K01258, K01257, K01256, K01255, K01254, K01253, K01252, K01251, K01250, K01249, K01248, K01247, K01246, K01245, K01244, K01243, K01242, K01241, K01240, K01239, K01238, K01237, K01236, K01235, K01234, K01233, K01232, K01231, K01230, K01229, K01228, K01227, K01226, K01225, K01224, K01223, K01222, K01221, K01220, K01219, K01218, K01217, K01216, K01215, K01214, K01213, K01212, K01211, K01210, K01209, K01208, K01207, K01206, K01205, K01204, K01203, K01201, K01197, K01196, K01195, K01194, K01193, K01192, K01191, K01190, K01189, K01188, K01187, K01186, K01185, K01184, K01183, K01182, K01181, K01180, K01179, K01178, K01177, K01176, K01175, K01174, K01173, K01172, K01171, K01170, K01169, K01168, K01167, K01166, K01165, K01164, K01163, K01162, K01161, K01160, K01159, K01158, K01157, K01156, K01155, K01154, K01153, K01152, K01151, K01150, K01149, K01148, K01147, K01146, K01145, K01144, K01143, K01142, K01141, K01140, K01139, K01138, K01137, K01136, K01135, K01134, K01133, K01132, K01131, K01130, K01129, K01128, K01127, K01126, K01125, K01124, K01123, K01122, K01121, K01120, K01119, K01118, K01117, K01116, K01115, K01114, K01113, K01112, K01111, K01110, K01109, K01108, K01107, K01106, K01105, K01104, K01103, K01102, K01101, K01100, K01099, K01098, K01097, K01096, K01095, K01094, K01093, K01092, K01091, K01090, K01089, K01088, K01087, K01086, K01085, K01084, K01083, K01082, K01081, K01080, K01079, K01078, K01077, K01076, K01075, K01074, K01073, K01072, K01071, K01070, K01069, K01068, K01067, K01066, K01065, K01064, K01063, K01062, K01061, K01060, K01059, K01058, K01057, K01056, K01055, K01054, K01053, K01052, K01051, K01050, K01049, K01048, K01047, K01046, K01045, K01044, K01043, K01042, K01041, K01040, K01039, K01038, K01037, K01036, K01035, K01034, K01033, K01032, K01031, K01030, K01029, K01028, K01027, K01026, K01025, K01024, K01022, K01021, K01020, K01019, K01018, K01017, K01016, K01013, K00064, K00063, K00062, K00061, K00060, K00058, K00056, K00055, K00054, K00053, K00052, K00051, K00050, K00049, K00048, K00047, K00046, K00045, K00044, K00043, K00042, K00041, K00040, K00039, K00038, K00037, K00036, K00035, K00034, K00033, K00032, K00031, K00030, K00029, K00005, K00004, and K00000.

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 Stryker Medical Division of Stryker

All 69

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Cub Pediatric Crib recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
17 Dec 2025Device	CLASS II	Stryker MV3 bariatric bed recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
17 Dec 2025Device	CLASS II	Stryker Arise 1000EX mattress recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
13 Dec 2023Device	CLASS II	ProCuity bed series recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
13 Dec 2023Device	CLASS II	ProCuity bed series recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide

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