# Z-0340-2023 (us_fda)

Recall of da Vinci Xi 8mm SureForm 30 stapler over staple-deployment failure / fragment risk; 2022.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_recall
- Status: recalled
- Filing number: Z-0340-2023
- Decision date: 2022-11-30
- Verification posture: verified

## Applicant

- [Intuitive Surgical](/companies/intuitive-surgical.md)

## Covered models (1)

- [da Vinci (and Ion)](/models/intuitive-da-vinci.md)

## Related incident

_Recall-is-both seam: this filing is paired with its incident-layer companion when the filing is a recall._

- [da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments](/incidents/davinci-sureform-stapler-fragment-recall-2022.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm)

_Canonical URL: /regulatory-filings/fda-recall-davinci-sureform-fragment-2022. HTML version: [/regulatory-filings/fda-recall-davinci-sureform-fragment-2022](/regulatory-filings/fda-recall-davinci-sureform-fragment-2022)._