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Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death

FDA's Class 1 recall record for Intuitive Surgical's 8 mm SureForm 30 Gray Reloads identifies a risk that incomplete staple lines could result in serious injury or death. FDA's safety communication instructs users to stop using affected reloads, quarantine them, and follow the manufacturer's return instructions (FDA recall record).

Occurred 2026-05-28 · 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.
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Sources (3)

  1. https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218985
  3. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death?
FDA's Class 1 recall record for Intuitive Surgical's 8 mm SureForm 30 Gray Reloads identifies a risk that incomplete staple lines could result in serious injury or death. FDA's safety communication instructs users to stop using affected reloads, quarantine them, and follow the manufacturer's return instructions ([FDA recall record](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218985)).
When did this incident occur?
The incident is recorded as occurring on May 28, 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 Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death?
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 Surgical recalls 8mm SureForm 30 Gray Reloads after patient death?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

2
primary-fda-database
FDA database
1
unclassified
Unclassified source

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

Methodology surface for Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death.

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Canonical ID 9e30e77f-6cf6-4933-bd52-671f5f6f471c