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)
Machine-readable surfaces
- Markdown mirror: /incidents/davinci-sureform-stapler-fragment-recall-2022.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/incidents/912e22fb-a60f-4f18-8f06-0e8304054fcd
- Data documentation: /data
Sources (1)
- RegDataLab (FDA mirror) · https://regdatalab.com/recall/Z-0340-2023
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) is the recorded robot involved in this incident.
- 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 · 1 source (no primary) · last reviewed 2026-06-04
Verification posture
Verified
Low confidence
Review state
Stable
Last reviewed 2026-06-04
Sources by quality tier
- 1
- unclassified
- Unclassified source
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.Canonical ID 912e22fb-a60f-4f18-8f06-0e8304054fcd