Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility
[RECALL]Dec 15, 2025 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Dec 15, 2025
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217850
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217850
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Details
Incident Context & FAQ
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.
What robot was involved in Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
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.