# FDA recall Z-0249-2020

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2018-06-04.

## Product

EndoWrist Suction Irrigator, Single Use Instrument.  Part Number: 480299-04.    An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

## Reason for recall

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

## Distribution

Worldwide distribution.  US nationwide, Australia, Italy, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-0249-2020
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-06-04
- **Report date:** 2019-11-06

- **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-0249-2020

## Citation

> AI Analytics. FDA recall Z-0249-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0249-2020. Source: US FDA. Licensed CC0.

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