Stryker Medical Division of Stryker Corporation: 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

Recall number

Z-1862-2012

Recalling firm

Stryker Medical Division of Stryker Corporation

Product

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

Status

Terminated

Initiated

2012-05-17

Posted

2012-06-22

Terminated

2014-05-12

Reason

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

Root cause

Component design/selection

Action

The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).

Quantity

2546

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

1831750

Firm city

Portage

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy