Medos International Sarl FDA Recalls

2 recalls on file across devices, 1 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Velys Enabling Tech Robotic-Assist Station REF: 451611001Class IIJul 23, 2026Software issue within robotic controller which may cause uni	Software issue within robotic controller which may cause unintended movement of the robotic arm during bone pr	Class IIDevices	Jul 23, 2026
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheClass IFeb 2, 2024Medos has received an increase in complaints for CEREBASE DA	Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the dis	Class IDevices	Feb 2, 2024