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Incident · Recall

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.

Occurred 2026-06-22 · 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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Machine-readable surfaces

Sources (2)

  1. 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
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=219527

Status history

  • Active · 2026-07-04 · agent:depth

Common questions

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.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

2
primary-fda-database
FDA database

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

Methodology surface for Intuitive Surgical recalls da Vinci SP1098 instrument.

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Canonical ID 69b91bdf-adcf-421f-9a70-dd3c1c994389