RobotRisk › Intuitive Surgical › 26 Feb 2025
Class II recall of da Vinci 5 foot pedal over spring failure
S3 · 26 Feb 2025 · Intuitive Surgical
Record
| Company | Intuitive Surgical |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 26 Feb 2025 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | da Vinci 5 systems, foot pedal component |
| Confidence | medium |
| Verified flag | Cited source on file; not independently re-verified |
Summary
FDA designated a recall of the Intuitive da Vinci 5 surgical robot system as Class II after the company warned customers of an increase in complaints about the foot tray pedal spring failing.
Primary source
Publisher: MassDevice · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 26 Feb 2025 | Class II recall of da Vinci 5 foot pedal over spring failure | MassDevice | MassDevice |
Intuitive Surgical other incidents timeline
Medical robotics context
recall context
Intuitive Surgical industry position
Related incidents
Other Intuitive Surgical entries
- 18 Mar 2026 - FDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries
- 11 Mar 2026 - Class I recall of da Vinci SureForm stapler reloads after patient death
- ~2025 - 2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures
- ~Sep 2021 - Lawsuit: da Vinci surgical robot burned woman's small intestine
- ~2013 - 14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)
- not documented - Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying
- not documented - NBC News 10-year MAUDE analysis of da Vinci adverse events
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