RegWardenFDA facility compliance records
Company

Umano Medical Inc

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2022: 1 recalls201720182019120202021120222023202420252026
  • Recalls (2)

Registered facilities (3)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Umano Medical Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10040948-umano-medical-inc/

Not open yet

Alerts for Umano Medical Inc

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.