AC-powered adjustable medical beds with built-in electric DC… — Class II medical device recall Z-1135-2022
Terminated recall by Umano Medical, Inc., reported 2022-06-01, distributed nationwide. There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure
| Recall number | Z-1135-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Umano Medical, Inc., L'Islet, Canada |
| Recall initiated | 2022-04-11 |
| Classified | 2022-05-26 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, IE |
| Quantity | 228 units |
| UPC / GTIN / UDI-DI | 00670482000487 |
| Serial numbers | FM100000451, FM100000452, FM100000453, FM100000454, FM100000455, FM100000456, FM100000457, FM100000458, FM100000482, FM100000483, FM100000484, FM100000485, FM100000486, FM100000487, FM100000488, FM100000489, FM100000490, FM100000491, FM100000507, FM100000508, FM100000509, FM100000510, FM100000511, FM100000512, FM100000513 and 203 more |
| Model numbers | FM1000 |
Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1135-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.