# FDA recall Z-1210-2022

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2022-03-03.

## Product

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

## Reason for recall

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

## Distribution

Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.

## Key facts

- **Recall number:** Z-1210-2022
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-03
- **Report date:** 2022-06-08

- **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-1210-2022

## Citation

> AI Analytics. FDA recall Z-1210-2022. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1210-2022. Source: US FDA. Licensed CC0.

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