# Z-1134-2026 (us_fda)

Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_recall
- Status: recalled
- Filing number: Z-1134-2026
- Filing date: 2025-12-04
- Decision date: 2026-01-28
- Verification posture: verified

## Applicant

- [Intuitive Surgical](/companies/intuitive-surgical.md)

## Covered models (1)

- [Ion Endoluminal System](/models/intuitive-ion.md)

## Sources (1)

- [https://api.fda.gov/device/recall.json?search=product_res_number:Z-1134-2026](https://api.fda.gov/device/recall.json?search=product_res_number:Z-1134-2026)

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