Velys Enabling Tech Robotic-Assist Station REF: 451611001 recall (Medos International Sarl)
Medical deviceClass IIOngoing
Summary: Medos International Sarl is recalling Velys Enabling Tech Robotic-Assist Station REF: 451611001. Reason: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
What is being recalled
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Why
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA. (states named: Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington)
How to tell if yours is affected
UDI: 10705034645995/Serial Numbers: W14316295301 W15316297501 W15316298001 W17316322901 W17316323301 W21316347401 W21316347501 W21316347601 W21316347801 W21316347901 W21316348001 W22316365801 W34316479001 W34316479101 W34316479201 W34316479301 W34316479401 W34316479601 W34316479801 W34316480001 W34316480101 W49316554301 W51316597001 W51316597101 Y03316603601 Y03316603701 Y03316603801 Y07316625901 Y15316690901
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3088-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 23, 2026 |
| Reported | September 9, 2026 |
| Company | Medos International Sarl |
| Company location | Le Locle, N/A, Switzerland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 29 stations |
More recalls from Medos International Sarl · all medical device recalls · recalls from July 2026