FDA recall, , Moderate risk
Medos International Velys Enabling Tech Robotic-Assist Station
The Velys Enabling Tech Robotic-Assist Station has a software issue that may cause unintended movement of the robotic arm.
Summary by Recall Canary from the FDA notice
What happened
Medos International Sarl, based in Le Locle, Switzerland, began a recall of the Velys Enabling Tech Robotic-Assist Station REF: 451611001 on July 23, 2026, 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 recall involves 29 stations and was added to the FDA's Enforcement Report on September 2, 2026.
The stations were distributed nationwide in the US states of Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Velys Enabling Tech Robotic-Assist Station REF: 451611001
- UDI-DI
- 10705034645995
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington.
- Company
- Medos International SarlLe Locle, Switzerland
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99467
- Recall number
- Z-3088-2026
- Quantity recalled
- 29 stations
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
