{"recall":{"id":"fda-device-99467","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medos International Sarl recalls Velys Enabling Tech Robotic-Assist Station REF: 451611001","firm":"Medos International Sarl","date":"2026-07-23","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Velys Enabling Tech Robotic-Assist Station REF: 451611001","code":"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","quantity":"29 stations","number":"Z-3088-2026","classification":"Class II"}],"reason":"Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.","nationwide":true,"states":[],"units":"29 stations","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99467","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b83a88051ae5745f","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99467","record":[{"status":"Ongoing","city":"Le Locle","state":"N/A","country":"Switzerland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99467","recalling_firm":"Medos International Sarl","address_1":"Chemin Blanc 36","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Visit","distribution_pattern":"US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.","recall_number":"Z-3088-2026","product_description":"Velys Enabling Tech Robotic-Assist Station   REF: 451611001","product_quantity":"29 stations","reason_for_recall":"Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.","recall_initiation_date":"20260723","center_classification_date":"20260902","report_date":"20260909","code_info":"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","more_code_info":""}]}}