# FDA recall Z-1134-2026

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2025-12-04.

## Product

Brand Name: Ion Endoluminal System  Product Name: Ion Vision Probe Bag  Model/Catalog Number: 490127  Software Version: N/A  Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures.     The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device.    The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar th

## Reason for recall

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

## Distribution

U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.  O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom

## Key facts

- **Recall number:** Z-1134-2026
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-04
- **Report date:** 2026-01-28

- **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-1134-2026

## Citation

> AI Analytics. FDA recall Z-1134-2026. Retrieved 2026-09-24 from https://api.ai-analytics.org/recall/Z-1134-2026. Source: US FDA. Licensed CC0.

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