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Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines

Intuitive Surgical recalled da Vinci 8mm SureForm 30 Gray Reloads (REF 48230M-05 / 48230M-06) because curved-tip stapler reloads could produce an incomplete staple line, creating a leak and bleeding risk. This is a Class I (most serious) recall. Source: FDA Class I device recall Z-1855-2026, accessdata.fda.gov / openFDA enforcement.

Occurred 2026-03-11 · Intuitive Surgical · Investigated by FDA

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Track Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines

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Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218985

Common questions

What happened in Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines?
Intuitive Surgical recalled da Vinci 8mm SureForm 30 Gray Reloads (REF 48230M-05 / 48230M-06) because curved-tip stapler reloads could produce an incomplete staple line, creating a leak and bleeding risk. This is a Class I (most serious) recall. Source: FDA Class I device recall Z-1855-2026, accessdata.fda.gov / openFDA enforcement.
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.
Who was involved in Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines?
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 Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

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

Methodology surface for Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines.

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Canonical ID 7f948d6b-ddb2-4257-8a97-34b4503db760