_Incident · Recall_

# da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)

Canonical ID: `e5e34795-0e48-49e1-8427-019ec1b1a86b`

- **Occurred:** 2026-03-11
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [da Vinci (and Ion)](/models/intuitive-da-vinci.md) (id: `45105ba4-1c1f-4121-9ad4-bb912db1dcfc`)

Intuitive recalled 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) after incomplete staple lines on blood vessels despite a 'completed' fire indication, linked to one patient death and four serious injuries (bleeding). Customer letter / quarantine Mar 11 2026; FDA classified Class I (reported May 2026). Blue/white reloads unaffected. Root cause stated 'still under investigation.' Cap-flag: exact recall Z-number + unit count not captured from primary FDA pages. Distinct from the 2022 SureForm fragment recall.

## Sources (1)

1. **MedTech Dive** · https://www.medtechdive.com/news/intuitive-surgical-recalls-stapler-reloads-over-issue-linked-to-patient-dea/815158/

## Common questions

### What happened in da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?

Intuitive recalled 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) after incomplete staple lines on blood vessels despite a 'completed' fire indication, linked to one patient death and four serious injuries (bleeding). Customer letter / quarantine Mar 11 2026; FDA classified Class I (reported May 2026). Blue/white reloads unaffected. Root cause stated 'still under investigation.' Cap-flag: exact recall Z-number + unit count not captured from primary FDA pages. Distinct from the 2022 SureForm fragment recall.

### When did this incident occur?

The incident is recorded as occurring on March 11, 2026 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 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?

da Vinci (and Ion) is the recorded robot involved in this incident.

### Has anyone responded to da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?

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 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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