The Recall Desk
Severity pendingFDA (Devices)·Z-1096-2026·Announced 2026-01-21

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.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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.

Distribution

Distributed nationwide across the United States.