# FDA recall Z-0841-2019

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-01-16.

## Product

daVinci Harmonic ACE Curved Shears

## Reason for recall

During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit.  The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.

## Distribution

US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom

## Key facts

- **Recall number:** Z-0841-2019
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-16
- **Report date:** 2019-02-27

- **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-0841-2019

## Citation

> AI Analytics. FDA recall Z-0841-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0841-2019. Source: US FDA. Licensed CC0.

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