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Incident · Recall

Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility

Intuitive recalled the da Vinci SP Access Port Kit (REF 430073 / 430075) because the Access Port System tray could develop cracks causing a sterility breach. 41,526 units. Source: FDA Class 2 device recall Z-1096-2026, openFDA enforcement / accessdata.fda.gov.

Occurred 2025-12-15 · Intuitive Surgical

Track Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility

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Common questions

What happened in Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility?
Intuitive recalled the da Vinci SP Access Port Kit (REF 430073 / 430075) because the Access Port System tray could develop cracks causing a sterility breach. 41,526 units. Source: FDA Class 2 device recall Z-1096-2026, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on December 15, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · no sources on file · last reviewed 2026-06-27

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-06-27

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility.

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Canonical ID b60405e4-1c4b-4885-97b2-539348f1e3e1