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Incident · Recall

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.

Occurred 2026-01-28 · da Vinci (and Ion) · Intuitive Surgical · Surgical robots · Investigated by FDA

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Track Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&recallnumber=Z-1134-2026
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217909

Common questions

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.
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.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-07-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

2
primary-fda-database
FDA database

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

Methodology surface for Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026).

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Canonical ID 8d33e5b8-a9a2-4a6c-84f8-bf7827ebcb4c