{"id":"9e30e77f-6cf6-4933-bd52-671f5f6f471c","slug":"recall-2026-05-28-intuitive-surgical","kind":"recall","headline":"Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death","summary":"Intuitive Surgical is recalling 8mm SureForm 30 Gray Reloads used by its da Vinci robot after incomplete deliveries failed to properly close, resulting in a patient death. FDA identified this as the most serious type of recall.","occurredAt":"2026-05-28T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"catastrophic","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,"createdAt":"2026-07-03T03:33:27.293Z","updatedAt":"2026-07-03T03:33:27.293Z","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"}],"aliases":["Intuitive","ISRG","da Vinci"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-06-28T13:52:14.998Z"},"derived":{"status":"active"},"sources":[{"id":"a6cd2993-ce2e-4393-9519-6a1d7695e817","incidentId":"9e30e77f-6cf6-4933-bd52-671f5f6f471c","url":"https://www.fiercebiotech.com/medtech/intuitive-recalls-surgical-stapler-reloads-following-patient-death","label":null,"publishedAt":null,"notes":null,"title":"Intuitive recalls surgical stapler reloads following patient death","sourceName":"Fierce Biotech","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T03:33:27.452Z","updatedAt":"2026-07-03T03:33:27.452Z"}],"responses":[],"statusEvents":[{"id":"5b419e65-f2a1-4c5b-9773-51c44205bb54","incidentId":"9e30e77f-6cf6-4933-bd52-671f5f6f471c","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T03:33:27.606Z","createdAt":"2026-07-03T03:33:27.607Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2026-05-28-intuitive-surgical","url":"https://registry.deploy.report/incidents/recall-2026-05-28-intuitive-surgical","headline":"Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death","description":"Intuitive Surgical is recalling 8mm SureForm 30 Gray Reloads used by its da Vinci robot after incomplete deliveries failed to properly close, resulting in a patient death. FDA identified this as the most serious type of recall.","identifier":"9e30e77f-6cf6-4933-bd52-671f5f6f471c","datePublished":"2026-05-28T12:00:00.000Z","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":[]}}}