RobotRisk › Intuitive Surgical › 11 Mar 2026
Class I recall of da Vinci SureForm stapler reloads after patient death
S5 · 11 Mar 2026 · Intuitive Surgical
Record
| Company | Intuitive Surgical |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 11 Mar 2026 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (fatality or catastrophic loss) |
| Scale | 1 death, 4 serious injuries; recall of affected lot to customers who ordered on/before Feb 20, 2026 |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
Intuitive recalled 8mm SureForm 30 gray stapler reloads for da Vinci curved-tip staplers after a patient died in December 2025 from surgical bleeding linked to incomplete staple line formation; four additional serious-injury reports of bleeding events were logged between January 2024 and January 2026.
Primary source
Publisher: FDA · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 11 Mar 2026 | Class I recall of da Vinci SureForm stapler reloads after patient death | FDA | FDA |
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
- 26 Feb 2025 - Class II recall of da Vinci 5 foot pedal over spring failure
- ~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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