RegWardenFDA facility compliance records
Facility

UMANO MEDICAL INC

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

Activity by year

FDA actions on record by year2019: 1 inspections; 2020: 1 recalls; 2022: 1 recalls2017201812019120202021120222023202420252026
  • Recalls (2)
  • Inspections (1)

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.

FDA inspections (1)

  • VAI2019-12-04
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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 3009591865) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009591865-umano-medical-inc/

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