The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2599-2021·Announced 2021-10-06

Stretch Leveller Model 3156200 May Lose Horizontal Position Control

Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from 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: This is a risk-of-harm medical device with potential for patient injury through falls or sliding, but no illnesses or injuries have been reported in the source material. Per the severity rubric, this is categorized as 'High' for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The recalled product is the Hill-Rom Stretch Leveller Model 3156200, a medical device designed to help healthcare workers lift and adjust patients while maintaining proper positioning. The device is intended to allow users to easily adjust and control the center of gravity during patient lifts.

The Stretch Leveller has a potential defect where it may lose its function of maintaining patients in a horizontal position while lifting and in motion. When this function fails, patients can slide backwards and may fall out of the lift sheet back onto the surface below.

Approximately 122 units have been distributed worldwide, including to 14 U.S. states (Arizona, California, Colorado, Delaware, Illinois, Maine, Michigan, Missouri, Mississippi, New Jersey, Ohio, Pennsylvania, Virginia, and Washington) and more than 25 countries internationally.

The recalled product

Product
Stretch Leveller Model Number: 3156200 - 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 Lifting / Mobility
Hazard
Affected units
122

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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