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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-1299
Request that the FDA immediately request intuitive issue a Class I recall of all Model 5 da Vinci Surgical Systems due to a serious intraoperative power failure defect causing prolonged reboot delay, loss of visualization and control, and potential insufflation loss in da Vinci 5 Models, publish an urgent medical device safety communication, and send a warning letter to
Documents
5
Comments
1
Description
OPEN
Key Dates
Comment Period OpensFeb 5, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDRH
Citizen Petition
Harmed Americans for Reform in
Medical-Device Safety Corp.
immediately request intuitive issue
a Class I recall of all Model 5 da Vinci
Surgical Systems due to a serious
intraoperative power failure defect
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