Z-1135-2022Class II

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

Name: Z-1135-2022 AC-powered adjustable medical beds with built-in electric DC actuators and controls
Creator: Umano Medical, Inc.
Published: 2022-04-11
License: https://open.fda.gov/license/

Umano Medical Inc. / initiated 2022-04-11 / Terminated / root cause: manufacturing process

FDA source

Umano Medical, Inc. began a recall of AC-powered adjustable medical beds with built-in electric DC actuators and controls on 2022-04-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1135-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-11
Posted: 2022-05-26
Terminated: 2024-01-17
Recalling firm: Umano Medical Inc.
Product: AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted.
Quantity in commerce: 228 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.
Product codes and lots: Model number: FM1000; UDI: 00670482000487; Serial Numbers: FM100000704, FM100000703, FM100000716, FM100000715, FM100000714, FM100000713, FM100000712, FM100000711, FM100000710, FM100000709, FM100000708, FM100000707, FM100000706, FM100000705, FM100000702, FM100000701, FM100000700, FM100000699, FM100000698, FM100000697, FM100000696, FM100000695, FM100000694, FM100000693, FM100000692, FM100000691, FM100000690, FM100000689, FM100000688, FM100000657, FM100000656, FM100000655, FM100000654, FM100000653, FM100000687, FM100000686, FM100000685, FM100000684, FM100000683, FM100000682, FM100000681, FM100000680, FM100000679, FM100000678, FM100000677, FM100000676, FM100000675, FM100000674, FM100000673, FM100000672, FM100000671, FM100000670, FM100000669, FM100000668, FM100000667, FM100000666, FM100000665, FM100000664, FM100000663, FM100000662, FM100000661, FM100000660, FM100000659, FM100000658, FM100000652, FM100000651, FM100000650, FM100000649, FM100000648, FM100000647, FM100000646, FM100000645, FM100000644, FM100000643, FM100000642, FM100000641, FM100000640, FM100000639, FM100000638, FM100000637, FM100000636, FM100000635, FM100000634, FM100000633, FM100000632, FM100000631, FM100000630, FM100000629, FM100000628, FM100000627, FM100000626, FM100000625, FM100000624, FM100000623, FM100000622, FM100000621, FM100000620, FM100000619, FM100000618, FM100000617, FM100000616, FM100000615, FM100000614, FM100000613, FM100000612, FM100000611, FM100000610, FM100000609, FM100000608, FM100000607, FM100000606, FM100000605, FM100000604, FM100000603, FM100000602, FM100000601, FM100000600, FM100000599, FM100000598, FM100000597, FM100000596, FM100000595, FM100000594, FM100000593, FM100000592, FM100000591, FM100000590, FM100000589, FM100000588, FM100000587, FM100000586, FM100000585, FM100000584, FM100000583, FM100000582, FM100000581, FM100000580, FM100000579, FM100000578, FM100000577, FM100000576, FM100000575, FM100000574, FM100000573, FM100000572, FM100000567, FM100000566, FM100000565, FM100000571, FM100000570, FM100000569, FM100000568, FM100000564, FM100000563, FM100000562, FM100000561, FM100000560, FM100000559, FM100000558, FM100000557, FM100000556, FM100000555, FM100000554, FM100000553, FM100000552, FM100000551, FM100000550, FM100000549, FM100000548, FM100000547, FM100000546, FM100000545, FM100000544, FM100000543, FM100000542, FM100000541, FM100000540, FM100000539, FM100000538, FM100000537, FM100000536, FM100000535, FM100000534, FM100000533, FM100000532, FM100000531, FM100000530, FM100000529, FM100000528, FM100000527, FM100000526, FM100000525, FM100000524, FM100000523, FM100000522, FM100000521, FM100000520, FM100000519, FM100000518, FM100000517, FM100000516, FM100000515, FM100000514, FM100000513, FM100000512, FM100000511, FM100000510, FM100000509, FM100000508, FM100000507, FM100000491, FM100000490, FM100000489, FM100000488, FM100000487, FM100000486, FM100000485, FM100000484, FM100000483, FM100000482, FM100000458, FM100000457, FM100000456, FM100000455, FM100000454, FM100000453, FM100000452, FM100000451

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1135-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1135-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-26
Z-1136-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-26

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)