_Incident · Recall_

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

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

- **Occurred:** 2022-10-07
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [da Vinci (and Ion)](/models/intuitive-da-vinci.md) (id: `45105ba4-1c1f-4121-9ad4-bb912db1dcfc`)

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).

## Sources (1)

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.


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