Velys Enabling Tech Robotic-Assist Station REF: recall status

Notice names this product. Medos International Sarl’s Velys Enabling Tech Robotic-Assist Station REF is named in FDA Class II recall Z-3088-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. Identifying details: 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. Units affected: 29 stations. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Velys Enabling Tech Robotic-Assist Station REF
Company / brand: Medos International Sarl
Lot / serial / date codes: 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.

Agency product description and boundaries

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Medos International Sarl

Recalls naming this model

FDA Class II · Medical device · September 9, 2026

Velys Enabling Tech Robotic-Assist Station REF recall — Medos International Sarl

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

Company / brand: Medos International Sarl recalls

Affected product: Velys Enabling Tech Robotic-Assist Station REF recall status

Official ID Z-3088-2026 · Official record ↗

See all Medos International Sarl recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.