The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2600-2021·Announced 2021-10-06

Patient Lift Device Stretch Leveller May Lose Horizontal Position Control

Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.

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: FDA Class II device with potential for serious patient injury (fall risk) from loss of horizontal position control during lifting. No illnesses or injuries have been reported; this is a risk-of-harm product where injury has not yet been realized.

Plain-English summary

The LikoStretch 1900 Model 3156051 is a patient lift device manufactured by Hill-Rom, Inc., designed to help healthcare workers lift and position patients. The device includes a Stretch Leveller component that is intended to maintain patients in a horizontal position during lifting and movement.

The Stretch Leveller component has the potential to lose its function of maintaining a patient in the horizontal position when lifting and in motion. When this loss of function occurs, patients can slide backwards and potentially fall out of the lift sheet back onto the surface being lifted from, creating a risk of serious patient injury.

The recalled device has been distributed worldwide, including throughout the United States in Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia, and Washington, as well as internationally in Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates. Facilities with the LikoStretch 1900 Model 3156051 should cease use and contact Hill-Rom, Inc. immediately for instructions regarding repair, replacement, or removal of the affected unit.

The recalled product

Product
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Manufacturer
Hill-Rom, Inc.
Category
Medical Device — Patient Lift
Hazard
Affected units
9

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 (1)

  • N/A

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Hill-Rom, 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 5 products in this recall →

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