# FDA recall Z-2380-2018

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2018-04-23.

## Product

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model  48645B-03, 12 reloads/box.

## Reason for recall

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

## Distribution

U.S., foreign and government accounts.  Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-2380-2018
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-23
- **Report date:** 2018-07-18
- **Termination date:** 2020-07-15

- **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-2380-2018

## Citation

> AI Analytics. FDA recall Z-2380-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2380-2018. Source: US FDA. Licensed CC0.

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