FDAClass IIJune 1, 2022

AC-powered adjustable medical beds with built-in recall

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

Why was AC-powered adjustable medical beds with built-in recalled?

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number: 200-0000; UDI: 00670482000487; Serial Numbers: 20004934, 20004933, 20004932, 20004931, 20004930, 20004929, 20004928, 20004927, 20004926, 20004925, 20004924, 20004923, 20004914, 20004886, 20004885, 20004884, 20004883, 20004882, 20004881, 20004880, 20004879, 20004878, 20004877, 20004876, 20004875, 20004874, 20004873, 20004872, 20004871, 20004870, 20004869, 20004868, 20004867, 20004866, 20004865, 20004864, 20004863, 20004862, 20004861, 20004860, 20004859, 20004858, 20004857, 20004856, 20004855, 20004854, 20004853, 20004852, 20004851, 20004850, 20004849, 20004848, 20004847, 20004846, 20004845, 20004844, 20004843, 20004842, 20004841, 20004840, 20004839, 20004812, 20004811, 20004810, 20004809, 20004808, 20004807, 20004806, 20004805, 20004804, 20004803, 20004802, 20004801, 20004800, 20004799, 20004798, 20004797, 20004796, 20004795, 20004794, 20004793, 20004792, 20004791, 20004790, 20004789, 20004788, 20004787, 20004786, 20004785, 20004784, 20004783, 20004782, 20004781, 20004712, 20004711, 20004710, 20004709, 20004777, 20004772, 20004721, 20004720, 20004719, 20004718, 20004717, 20004662, 20004661, 20004660, 20004659, 20004658, 20004657, 20004656, 20004655, 20004654, 20004653, 20004652, 20004651, 20004708, 20004707, 20004706, 20004705, 20004704, 20004703, 20004702, 20004701, 20004700, 20004699, 20004698, 20004697, 20004696, 20004695, 20004694, 20004693, 20004692, 20004691, 20004690, 20004689, 20004688, 20004687, 20004686, 20004685, 20004684, 20004683, 20004682, 20004681, 20004680, 20004679, 20004678, 20004677, 20004676, 20004675, 20004674, 20004673, 20004650, 20004649, 20004648, 20004647, 20004646, 20004645, 20004644, 20004643, 20004642, 20004641, 20004640, 20004639, 20004638, 20004637, 20004636, 20004627, 20004626, 20004625, 20004624, 20004623, 20004622, 20004621, 20004620, 20004619, 20004618, 20004617, 20004616, 20004615, 20004614, 20004613, 20004612, 20004611, 20004610, 20004609, 20004608, 20004607, 20004606, 20004605, 20004542, 20004541, 20004540, 20004539, 20004538, 20004537, 20004536, 20004535, 20004534, 20004533, 20004532, 20004531, 20004530, 20004529, 20004528, 20004527, 20004526, 20004525, 20004524, 20004523, 20004522, 20004521, 20004520, 20004519, 20004518, 20004517, 20004516, 20004515, 20004514, 20004513, 20004512, 20004511, 20004510, 20004509, 20004508, 20004507, 20004506, 20004505, 20004504, 20004503, 20004502, 20004501, 20004500, 20004499, 20004498, 20004497, 20004496, 20004495, 20004494, 20004493, 20004492, 20004491, 20004490, 20004489, 20004488, 20004487, 20004486, 20004485, 20004484, 20004483, 20004482, 20004481, 20004480, 20004479, 20004478, 20004477, 20004476, 20004475, 20004474, 20004473, 20004466, 20004465, 20004464, 20004463, 20004462, 20004461, 20004460, 20004459, 20004458, 20004457, 20004456, 20004455, 20004454, 20004453, 20004452, 20004451, 20004450, 20004449, 20004448, 20004447, 20004446, 20004445, 20004444, 20004443, 20004442, 20004441, 20004440, 20004439, 20004438, 20004437, 20004417, 20004416, 20004415, 20004414, 20004413, 20004412, 20004374, 20004373, 20004372, 20004371, 20004370, 20004369, 20004368, 20004367, 20004366, 20004247, 20004246, 20004380, 20004220, 20004219, 20004218, 20004210, 20004209, 20004208, 20004207, 20004206, 20004205, 20004204, 20004203, 20004202, 20004035, 20004034, 20004033, 20004032, 20004031, 20004030, 20004029, 20004028, 20004027, 20004022, 20004023, 20004024, 20004025, 20004026, 20004238, 20004239, 20004240, 20004241, 20004242, 20004243, 20004244, 20004248, 20004249, 20004250, 20004251, 20004252, 20004332, 20004333, 20004375, 20004376, 20004377, 20004378, 20004379, 20004835, 20004245

Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Recalling firm
Umano Medical, Inc.
Quantity
355 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.
Recall date
June 1, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls