# FDA recall Z-2329-2020

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-12-19.

## Product

STAINLESS STEEL REPROCESSING TRAY,  2D CAMERA HEAD, IS4000, Model No. 400499-03  - Product Usage: is designed to enable complex surgery using a minimally invasive approach.

## Reason for recall

Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of  Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, Maine, Massachusetts, Nevada, New York, North Dakota, Nebraska, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington and West Virginia. Multiple countries including Canada.

## Key facts

- **Recall number:** Z-2329-2020
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-19
- **Report date:** 2020-06-17
- **Termination date:** 2023-08-31

- **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-2329-2020

## Citation

> AI Analytics. FDA recall Z-2329-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2329-2020. Source: US FDA. Licensed CC0.

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