CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

Velys Enabling Tech Robotic-Assist Station recalled

Medos International Sarl is recalling Velys Enabling Tech Robotic-Assist Station, distributed nationwide in the US. The recall was initiated on 23 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled29 stations

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3088-2026
FDA event ID: 99467
Recalling firm: Medos International Sarl, Le Locle, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 23 Jul 2026
FDA classified: 2 Sep 2026
Reported: 9 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

23 Jul 2026	Recall initiated by company
2 Sep 2026	Classified by FDA	+41 days
9 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Where it was distributed

US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.

Nationwide Florida Illinois Kentucky Maryland Michigan Minnesota New Jersey New Mexico New York Oregon Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.

Which lots are 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

Where was it sold?

US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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