The Recall Desk
HighFDA (Devices)·Z-1136-2022·Announced 2022-06-01

Medical beds recalled for potential motorized wheel system failure

Umano Medical is recalling 355 adjustable medical beds because an electrical system component failure could cause the motorized wheel system to move uncontrollably, risking patient injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving potential patient injury from uncontrolled motorized motion. No illnesses or injuries have been reported; the hazard is based on possible electrical component failure. Per rubric criteria, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Umano Medical, Inc. is recalling 355 AC-powered adjustable medical beds (Model 200-0000) because an electrical system component may fail, potentially causing the motorized wheel system to move continuously without stopping.

The motorized wheel system is designed to be controlled through the bed's electrical controls. If a component in the electrical system fails, the wheels could enter an uninterrupted motion state, potentially resulting in patient injury or device damage.

The recalled beds have been distributed in 18 U.S. states (California, Pennsylvania, Alabama, Georgia, Arizona, Minnesota, Florida, Washington, Oklahoma, New York, North Dakota, Arkansas, Missouri, North Carolina, Utah, Texas, and Wisconsin) and internationally to Australia, Ireland, and Canada. Affected units can be identified by Model 200-0000 and specific serial numbers provided by the manufacturer.

Consumers and healthcare facilities with affected beds should stop using them immediately and contact Umano Medical, Inc. for further instructions on repair, replacement, or return. Additional information is available using FDA recall number Z-1136-2022.

The recalled product

Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Manufacturer
Umano Medical, Inc.
Category
Medical Device — Patient Mobility Equipment
Hazard
Affected units
355

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model number: 200-0000
  • UDI: 00670482000487
  • Serial Numbers: 20004934
  • 20004933
  • 20004932
  • 20004931
  • 20004930
  • 20004929
  • 20004928
  • 20004927
  • 20004926
  • 20004925
  • 20004924
  • 20004923
  • 20004914
  • 20004886
  • 20004885
  • 20004884
  • 20004883
  • 20004882

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Umano Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Umano Medical, Inc.

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Same hazard · uncontrolled motion

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