Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death
[RECALL]May 28, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
May 28, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Intuitive Surgical is recalling 8mm SureForm 30 Gray Reloads used by its da Vinci robot after incomplete deliveries failed to properly close, resulting in a patient death. FDA identified this as the most serious type of recall.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death
https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death
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Details
Incident Context & FAQ
What happened in Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death?
Intuitive Surgical is recalling 8mm SureForm 30 Gray Reloads used by its da Vinci robot after incomplete deliveries failed to properly close, resulting in a patient death. FDA identified this as the most serious type of recall.
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.