FDA Medical devices recall ·
Velys Enabling Tech Robotic-Assist Station recall
- Recall number
- Z-3088-2026
- Date
- (initiated July 23, 2026)
- Company / brand
- Medos International Sarl
Chemin Blanc 36, Le Locle, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29 stations
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Why was it recalled?
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.
States: Delaware Florida Illinois Kentucky Maryland Michigan Minnesota New Jersey New Mexico New York Oregon Pennsylvania Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3088-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.