# FDA recall Z-1192-2019

> **Medrobotics Corporation** · Class II · device recall initiated 2019-01-25.

## Product

Obturator (shortcone), Part number 26114    Product Usage:  The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

## Reason for recall

The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

## Distribution

Worldwide Distribution - US Nationwide in the states of  CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.

## Key facts

- **Recall number:** Z-1192-2019
- **Recalling firm:** Medrobotics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-25
- **Report date:** 2019-04-24
- **Termination date:** 2020-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raynham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2019

## Citation

> AI Analytics. FDA recall Z-1192-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1192-2019. Source: US FDA. Licensed CC0.

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