Which foreign-made robots have been involved in US-regulator incidents?

Every incident, most recent first

1. FDA grants De Novo authorization to Vitestro Aletta, first standalone robotic blood draw device

   regulatory actionmoderateFDAother

   by Vitestro(Nieuwegein, Netherlands)
   2026-08-19
2. FCC effectively bans new foreign-made advanced robotic devices citing national security risks, primarily targeting Chinese manufacturers like Unitree

   regulatory actionseriousFCCsuspension

   by Unitree Robotics(Hangzhou, China)
   2026-07-29
3. FCC bans imports of new Chinese-made humanoid and quadruped robots, citing national security risks

   regulatory actionseriousFCCsuspension

   Unitree G1 by Unitree Robotics(Hangzhou, China)
   2026-07-28
4. FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches

   regulatory actionmoderateFDAother

   ANOVO by Momentis Surgical(Yokne'am Illit, Israel)
   2026-07-23
5. Medtronic Hugo surgical robot earns FDA clearance for additional indication

   regulatory actionminorFDAother

   Hugo RAS by Medtronic(Dublin, Ireland)
   2026-07-01
6. LEM Surgical receives FDA clearance for Dynamis multi-arm surgical robot

   regulatory actionminorFDAother

   Dynamis Robotic Surgical System by LEM Surgical(Bern, Switzerland)
   2026-07-01
7. FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures

   regulatory actionminorFDAother

   Versius by CMR Surgical(Cambridge, United Kingdom)
   2026-07-01
8. LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system

   regulatory actionminorFDAother

   Dynamis Robotic Surgical System by LEM Surgical(Bern, Switzerland)
   2026-06-23
9. Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications

   regulatory actionminorFDAother

   Dexter by Distalmotion(Lausanne, Switzerland)
   2026-06-15
10. Revolve Surgical receives FDA 510(k) clearance for surgical robot platform

    regulatory actionminorFDAother

    Revolve Surgical Platform by Revolve Surgical(Canada)
    2026-06-15
11. FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly

    recallcatastrophicFDArecall ordered

    ROSA by Zimmer Biomet(Warsaw, IN)
    2026-06-15
12. CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability

    recallmoderateFDArecall ordered

    Versius by CMR Surgical(Cambridge, United Kingdom)
    2026-06-09
13. Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers

    regulatory actionminorFDAother

    Epione by Quantum Surgical(Montpellier, France)
    2026-03-26
14. CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery

    regulatory actionminorFDAother

    Versius by CMR Surgical(Cambridge, United Kingdom)
    2026-03-15
15. Medtronic Hugo robotic surgery system cleared by FDA for urologic procedures

    regulatory actionminorFDAother

    Hugo RAS by Medtronic(Dublin, Ireland)
    2026-02-15
16. FCC added foreign-produced UAS (DJI, Autel) to the Covered List, blocking new US authorizations

    regulatory actionseriousFCCsuspension

    DJI Mavic 4 Pro by DJI(Shenzhen, China)
    2025-12-22
17. FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))

    regulatory actionminorFDAother

    Versius by CMR Surgical(Cambridge, United Kingdom)
    2025-12-17
18. FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy

    regulatory actionmoderateFDAother

    Versius by CMR Surgical(Cambridge, United Kingdom)
    2025-12-16
19. FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures

    regulatory actionmoderateFDAother

    Hugo RAS by Medtronic(Dublin, Ireland)
    2025-12-03