Answer
Which foreign-made robots have been involved in US-regulator incidents?
The cross-cut nobody else publishes. As of 2026-08-24, 18 incidents on the DEPLOY registry involved a robot manufactured outside the US AND triggered a file by a US regulator (NHTSA, FAA, FDA, FCC, USCG, OSHA, CPSC).
By US regulator
- FDA15
- FCC3
By maker origin (best-effort)
- United Kingdom5
- China3
- Switzerland3
- Ireland3
- Israel1
- IN1
- Canada1
- France1
Every incident, most recent first
- FCC effectively bans new foreign-made advanced robotic devices citing national security risks, primarily targeting Chinese manufacturers like Unitree2026-07-29regulatory actionseriousFCCsuspension
by Unitree Robotics(Hangzhou, China)
- FCC bans imports of new Chinese-made humanoid and quadruped robots, citing national security risks2026-07-28regulatory actionseriousFCCsuspension
Unitree G1 by Unitree Robotics(Hangzhou, China)
- FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches2026-07-23regulatory actionmoderateFDAother
ANOVO by Momentis Surgical(Yokne'am Illit, Israel)
- LEM Surgical receives FDA clearance for Dynamis multi-arm surgical robot2026-07-01regulatory actionminorFDAother
Dynamis Robotic Surgical System by LEM Surgical(Bern, Switzerland)
- Medtronic Hugo surgical robot earns FDA clearance for additional indication2026-07-01regulatory actionminorFDAother
- FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures2026-07-01regulatory actionminorFDAother
Versius by CMR Surgical(Cambridge, United Kingdom)
- LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system2026-06-23regulatory actionminorFDAother
Dynamis Robotic Surgical System by LEM Surgical(Bern, Switzerland)
- FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly2026-06-15recallcatastrophicFDArecall ordered
ROSA by Zimmer Biomet(Warsaw, IN)
- Revolve Surgical receives FDA 510(k) clearance for surgical robot platform2026-06-15regulatory actionminorFDAother
Revolve Surgical Platform by Revolve Surgical(Canada)
- Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications2026-06-15regulatory actionminorFDAother
Dexter by Distalmotion(Lausanne, Switzerland)
- CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability2026-06-09recallmoderateFDArecall ordered
Versius by CMR Surgical(Cambridge, United Kingdom)
- Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers2026-03-26regulatory actionminorFDAother
Epione by Quantum Surgical(Montpellier, France)
- CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery2026-03-15regulatory actionminorFDAother
Versius by CMR Surgical(Cambridge, United Kingdom)
- Medtronic Hugo robotic surgery system cleared by FDA for urologic procedures2026-02-15regulatory actionminorFDAother
- FCC added foreign-produced UAS (DJI, Autel) to the Covered List, blocking new US authorizations2025-12-22regulatory actionseriousFCCsuspension
DJI Mavic 4 Pro by DJI(Shenzhen, China)
- FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))2025-12-17regulatory actionminorFDAother
Versius by CMR Surgical(Cambridge, United Kingdom)
- FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy2025-12-16regulatory actionmoderateFDAother
Versius by CMR Surgical(Cambridge, United Kingdom)
- FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures2025-12-03regulatory actionmoderateFDAother
Related answers
- Robotics incidents by severity
Every tracked robotics incident cut by the severity ladder. Catastrophic + critical listed in full.
Best-effort classification. Foreign-manufactured determined by the maker’s HQ text (no US state / country marker). US regulator determined by an incident’s regulatory_body matching one of NHTSA, FAA, FDA, FCC, USCG, OSHA, CPSC. Rebuilt every 15 minutes.