Facility

Umano Medical Inc.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3043625036
Establishment type	Manufacture Medical Device
Location	670 rue Joseph-Louis-Mathieu Sherbrooke Quebec, CA J1R 0X3
Registration status	Active · expires 2026
Parent company	Umano Medical Inc (owner-operator 10040948)
Brand names	Echo-Flex 5002

Activity by year

Recalls (2)

Devices registered here (1)

Table, Examination, Medical, Powered
Product code LGX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4960

Recalls & enforcement

Class IITerminated2022-04-11
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.
Class IITerminated2020-05-04
Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Umano Medical Inc. (FEI 3043625036) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3043625036-umano-medical-inc/

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