The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2597-2021·Announced 2021-10-06

Patient lift device may lose horizontal positioning control, creating fall risk

The OctoStretch with Stretch Leveller may lose its ability to keep patients horizontal during lifting, risking patient falls. 440 units were distributed worldwide.

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 device with a documented potential for patient harm (fall risk) but no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injuries score High (3).

Plain-English summary

The OctoStretch with Stretch Leveller (Model 3156056), manufactured by Hill-Rom, Inc., is a patient-handling device designed to assist with lifting and positioning patients while maintaining horizontal alignment.

The device has a potential defect: the Stretch Leveller component may lose its function to maintain patients in a horizontal position during lifting and movement. When this occurs, patients can slide backwards and potentially fall out of the device onto the surface below.

Approximately 440 units were distributed in the United States across 15 states and internationally to more than 30 countries worldwide.

Healthcare facilities and users of this device should verify they have the affected model and contact Hill-Rom, Inc. for guidance on the hazard and potential remediation or replacement options.

The recalled product

Product
OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
Manufacturer
Hill-Rom, Inc.
Category
Medical Device — Patient Handling / Mobility
Hazard
Affected units
440

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 →

Related recalls

Same manufacturer · Hill-Rom, Inc.

See all →

Same hazard · fall risk

See all →

Similar recalls