Medos International Sarl recall: Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl is recalling Velys Enabling Tech Robotic-Assist Station REF: 451611001 – 29 stations. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on July 23, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Velys Enabling Tech Robotic-Assist Station REF: 451611001 |
| Brand | Medos International Sarl |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 23, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 29 stations |
| Recall ID | 99467 |
Recalled products
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- FDA recall number
- Z-3088-2026
- Codes, lots and dates
- 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
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99467
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Le Locle, N/A, Switzerland
Why it was recalled
The reason the FDA lists: “Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of DE, FL, IL, KY, MD, MI, MN, NJ, NM, NY, OR, PA, TN, TX, VA, WA.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99467, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
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|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Medos International Sarl Velys Enabling Tech Robotic-Assist Station REF: 451611001 recalled?
Yes. Medos International Sarl recalled it on July 23, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
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 I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.