Velys Enabling Tech Robotic-Assist Station REF: 451611001 — Class II medical device recall Z-3088-2026
Ongoing recall by Medos International Sarl, reported 2026-09-09, distributed nationwide. Software issue within robotic controller which may cause unintended movement of the robotic arm during bone pr
| Recall number | Z-3088-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medos International Sarl, Le Locle, N/A, Switzerland |
| Recall initiated | 2026-07-23 |
| Classified | 2026-09-02 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 29 stations |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 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 and 4 more |
| Model numbers | 451611001 |
Product
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Reason for recall
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3088-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.