da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 15, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | Intuitive Surgical, Inc. |
| Country / region | United States CA |
Hazard
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Affected products
- da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
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