The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1135-2022·Announced 2022-06-01

Medical beds with motorized wheels face uncontrolled motion risk

Umano Medical recalls 228 adjustable hospital beds due to potential electrical system failure that could cause uncontrolled movement of the motorized wheel system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall involving a theoretical risk of patient harm from uncontrolled motorized bed motion, but no injuries or deaths have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Umano Medical is recalling 228 AC-powered adjustable medical beds (Model FM1000) due to a potential hazard in the electrical system that could cause uninterrupted motion of the motorized wheel system.

The motorized wheel system is designed to be controlled and stationary when not in operation. A failure in a component of the electrical system could prevent the wheels from stopping, creating a risk of uncontrolled bed movement.

The recalled beds were distributed worldwide, including to 18 US states (California, Pennsylvania, Alabama, Georgia, Arizona, Minnesota, Florida, Washington, Oklahoma, New York, North Dakota, Arkansas, Missouri, North Carolina, Utah, Texas, and Wisconsin) as well as Australia, Ireland, and Canada.

Umano Medical is contacting facilities and users of the affected beds directly. Consumers or facilities with a recalled bed should stop using it and contact Umano Medical immediately for instructions on repair or replacement options.

The recalled product

Product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Manufacturer
Umano Medical, Inc.
Category
Medical Device
Hazard
Affected units
228

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: FM1000
  • UDI: 00670482000487
  • Serial Numbers: FM100000704
  • FM100000703
  • FM100000716
  • FM100000715
  • FM100000714
  • FM100000713
  • FM100000712
  • FM100000711
  • FM100000710
  • FM100000709
  • FM100000708
  • FM100000707
  • FM100000706
  • FM100000705
  • FM100000702
  • FM100000701
  • FM100000700
  • FM100000699

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 →

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