Intuitive Surgical recalls da Vinci SP1098 instrument

[RECALL]

Jun 22, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea

Failure Mode

RECALL

Event Date

Jun 22, 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 issued a recall for the da Vinci ASSY PSS SP1098 part number 38060115, listed in the FDA medical device recall database on June 22 2026. This follows prior recalls of SureForm 30 stapler reloads after incomplete staple lines were reported.

System & Fleet Architecture

Operating Manufacturer

Intuitive SurgicalView Manufacturer

Hardware Platform

da Vinci (and Ion)

Operational Sectors

Primary Sources & Evidentiary Filings

  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=Intuitive&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=100

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=Intuitive&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=100

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Intuitive Surgical recalls da Vinci SP1098 instrument?

Intuitive Surgical issued a recall for the da Vinci ASSY PSS SP1098 part number 38060115, listed in the FDA medical device recall database on June 22 2026. This follows prior recalls of SureForm 30 stapler reloads after incomplete staple lines were reported.

When did this incident occur?

The incident is recorded as occurring on June 22, 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 da Vinci SP1098 instrument?

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 da Vinci SP1098 instrument?

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 da Vinci SP1098 instrument?

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