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RobotRisk / Intuitive Surgical / 2026-03-11
medical robotics · recall

Class I recall of da Vinci SureForm stapler reloads after patient death

S5 · 03/11
2026 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typerecall
Date03/11
2026
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS5 (fatality or catastrophic loss)
Scale1 death, 4 serious injuries; recall of affected lot to customers who ordered on/before Feb 20, 2026
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceFDA

What happened

Intuitive recalled 8mm SureForm 30 gray stapler reloads for da Vinci curved-tip staplers after a patient died in December 2025 from surgical bleeding linked to incomplete staple line formation; four additional serious-injury reports of bleeding events were logged between January 2024 and January 2026.

Intuitive Surgical record context

Entries by year and severity

2374742020 S3: 842020 S5: 387202021 S3: 1292021 S4: 12021 S5: 3133212022 S3: 1202022 S5: 10130222023 S3: 1882023 S5: 2190232024 S3: 2452024 S5: 7252242025 S3: 4702025 S5: 4474252026 S3: 3812026 S5: 838926
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Comparable recall events in medical robotics

SevDateCompanyEvent
S22026-06-09CMR SurgicalClass II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S42026-03-25OmnicellFDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S32026-01-21Auris Health (J&J MedTech)FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S32025-09-12Noah MedicalFDA Class II recall: Brand Name: Galaxy System
S32025-05-23Quantum SurgicalFDA Class II recall: EPIONE Model 30-0001
S32025-04-23Virtual IncisionFDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S32025-02-26Intuitive SurgicalClass II recall of da Vinci 5 foot pedal over spring failure
S32024-10-28Noah MedicalFDA Class II recall: Galaxy System (GAL-001).

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