The Recall Desk
HighFDA (Devices)·Z-3088-2026·Announced 2026-09-09

Medos Velys Robotic-Assist Station Recalled for Software Movement Issue

Medos International Sarl is recalling 29 Velys Robotic-Assist Stations due to a software issue that may cause unintended robotic arm movement during surgery.

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: The recall involves a medical device with a risk of unintended movement during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Medos International Sarl is recalling 29 units of the Velys Enabling Tech Robotic-Assist Station (REF: 451611001). The recall is due to a software issue within the robotic controller that may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

The affected devices were distributed nationwide in the United States, specifically in the states of Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington. The recall is classified as Class II by the FDA.

Healthcare facilities should contact Medos International Sarl for instructions on how to address the software issue. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns.

The recalled product

Product
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Manufacturer
Medos International Sarl
Category
Medical Device — Surgical Robotics
Hazard
Affected units
29

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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