Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines
[RECALL]Mar 11, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
RECALL
Event Date
Mar 11, 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 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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218985
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=218985
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Details
Incident Context & FAQ
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.
What robot was involved in Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
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.