{"id":"a2ea56b5-a224-4b06-bf36-e19b7398cf22","slug":"recall-2026-04-15-intuitive-surgical","kind":"recall","headline":"Intuitive Surgical recalls da Vinci staplers after death and injuries","summary":"Intuitive Surgical recalled its da Vinci surgical staplers after reports of death and injuries. The FDA received a petition requesting a voluntary recall of the da Vinci 5 system due to safety concerns with the stapling functionality.","occurredAt":"2026-04-15T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-08T14:58:28.151Z","updatedAt":"2026-07-08T14:58:28.151Z","model":null,"deployment":null,"company":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","name":"Intuitive Surgical","slug":"intuitive-surgical","description":"Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the [da Vinci](/models/intuitive-da-vinci) teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.","status":"public (NASDAQ: ISRG)","founded":1995,"hq":"Sunnyvale, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm","title":"Intuitive Form 10-Q (Q1 2026): 11,395 da Vinci installed (1,464 da Vinci 5); 1,041 Ion","sourceName":"SEC EDGAR"},{"url":"https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm","title":"Intuitive Q1 2026 earnings (procedures +17%; 431 da Vinci placed; revenue $2.77B)","sourceName":"SEC EDGAR"},{"url":"https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html","title":"Intuitive: FDA clearance of da Vinci 5 (510(k), Mar 14 2024; Force Feedback)","sourceName":"Intuitive (GlobeNewswire)"},{"url":"https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/","title":"Intuitive demos 4,000-mile telesurgery (investigational, in development)","sourceName":"The Robot Report"}],"keyFacts":[{"label":"Installed base","value":"11,395 da Vinci (1,464 da Vinci 5) + 1,041 Ion (SEC 10-Q, Q1 2026)."},{"label":"Gating events","value":"da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Stock listing","value":"NASDAQ: ISRG"},{"label":"Market position","value":"Dominant surgical-robotics maker"},{"label":"da Vinci product type","value":"Teleoperated surgical robot"},{"label":"Ion product type","value":"Robotic bronchoscopy system"},{"label":"Hero image candidate","value":"https://upload.wikimedia.org/wikipedia/commons/7/77/New_Da_Vinci_Xi.jpg (source: Wikimedia Commons, license: CC BY-SA 4.0)"}],"aliases":["Intuitive","ISRG","da Vinci"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-07-07T21:55:07.582Z"},"derived":{"status":"active"},"sources":[{"id":"51935895-dbf5-4e0b-9ea9-0d9649320253","incidentId":"a2ea56b5-a224-4b06-bf36-e19b7398cf22","url":"https://www.mddionline.com/surgical/from-cyber-criminals-to-recalls-inside-intuitive-surgical-s-newest-snag","label":null,"publishedAt":null,"notes":null,"title":"Intuitive Surgical Recalls Staplers After Death, Injuries","sourceName":"MDDIO","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-08T14:58:28.534Z","updatedAt":"2026-07-08T14:58:28.534Z"}],"responses":[],"statusEvents":[{"id":"dcd932a7-687d-49c5-9daf-37a79b50ddb2","incidentId":"a2ea56b5-a224-4b06-bf36-e19b7398cf22","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-08T14:58:28.919Z","createdAt":"2026-07-08T14:58:28.920Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2026-04-15-intuitive-surgical","url":"https://registry.deploy.report/incidents/recall-2026-04-15-intuitive-surgical","headline":"Intuitive Surgical recalls da Vinci staplers after death and injuries","description":"Intuitive Surgical recalled its da Vinci surgical staplers after reports of death and injuries. The FDA received a petition requesting a voluntary recall of the da Vinci 5 system due to safety concerns with the stapling functionality.","identifier":"a2ea56b5-a224-4b06-bf36-e19b7398cf22","datePublished":"2026-04-15T12:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}