[pending] da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) &
Pending LLM rewrite. Source: FDA_DEVICE Z-1096-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Access Port System tray may develop cracks potentially resulting in a sterility breach.
The recalled product
- Product
- da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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