Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)
[RECALL]Jan 28, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Jan 28, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
FDA Class II recall Z-1134-2026 (posted 2026-01-28): probe-bag sterile-seal issue in the Intuitive Ion Endoluminal System.
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?start_search=1&recallnumber=Z-1134-2026
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&recallnumber=Z-1134-2026
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217909
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217909
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Details
Incident Context & FAQ
What happened in Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)?
FDA Class II recall Z-1134-2026 (posted 2026-01-28): probe-bag sterile-seal issue in the Intuitive Ion Endoluminal System.
When did this incident occur?
The incident is recorded as occurring on January 28, 2026 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 Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)?
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 Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.