# FDA recall Z-2720-2024

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2024-07-12.

## Product

Ion Endoluminal System, REF: 380748-65

## Reason for recall

There is a potential that the robotic system's instrument  cart arm  may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.

## Distribution

US Nationwide distribution in the states of AZ and CA.

## Key facts

- **Recall number:** Z-2720-2024
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-12
- **Report date:** 2024-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2024

## Citation

> AI Analytics. FDA recall Z-2720-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2720-2024. Source: US FDA. Licensed CC0.

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