DEPLOYDatabase

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 · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility

Machine-readable surfaces

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217850

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: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

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.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

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