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Incident · Recall

da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments

FDA recall Z-0340-2023 (Class II; initiated Oct 7 2022): potential staple deployment failure and intraoperative device-fragment generation on da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads. Distinct from the 2026 gray-reload Class I death recall (different year/class/failure mode).

Occurred 2022-10-07 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments

Machine-readable surfaces

Outcomes (1)

  • regulatory actionverified

Revision history (1)

  • 2026-06-05 · outcome_class

Outcome rows carry verification_posture independently. Revision events carry basis (verified_court_filing, verified_insurance, reported_press, estimate, undisclosed). The framework records outcomes only when verifiable; absence is honest absence, not a claim of no-impact.

Sources (2)

  1. RegDataLab (FDA mirror) · https://regdatalab.com/recall/Z-0340-2023
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=196688

Common questions

What happened in da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
FDA recall Z-0340-2023 (Class II; initiated Oct 7 2022): potential staple deployment failure and intraoperative device-fragment generation on da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads. Distinct from the 2026 gray-reload Class I death recall (different year/class/failure mode).
When did this incident occur?
The incident is recorded as occurring on October 7, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (1 primary) · last reviewed 2026-07-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

1
unclassified
Unclassified source
1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments.

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Canonical ID 912e22fb-a60f-4f18-8f06-0e8304054fcd