{"id":"8c7919af-a019-4ce8-9af5-954e718b9d42","slug":"davinci-x-xi-usm-cannula-screw-recall-2026","kind":"recall","headline":"Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)","summary":"On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.","occurredAt":"2026-04-02T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":"mechanical_failure","rootCauseDetail":"Screws on the cannula mount of the Universal Surgical Manipulator susceptible to breaking over time; if all six break, mount can separate causing imprecise instrument motion","affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":"in_progress","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":"2026-07-14T21:03:01.385Z","updatedAt":"2026-07-14T21:53:38.800Z","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","lifecycleState":"active","supersededByCompanyId":null,"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":"59627efb-8069-4131-a930-aca0251690c0","incidentId":"8c7919af-a019-4ce8-9af5-954e718b9d42","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=219087","label":"FDA Medical Device Recall Database","publishedAt":"2026-05-01T00:00:00.000Z","notes":null,"title":null,"sourceName":"FDA Medical Device Recall Database","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-14T21:03:01.385Z","updatedAt":"2026-07-14T21:03:01.385Z"}],"responses":[],"statusEvents":[{"id":"23657888-b5b8-4ca7-9a86-1cd1170a3ce1","incidentId":"8c7919af-a019-4ce8-9af5-954e718b9d42","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-14T21:03:02.668Z","createdAt":"2026-07-14T21:03:02.668Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/davinci-x-xi-usm-cannula-screw-recall-2026","url":"https://registry.deploy.report/incidents/davinci-x-xi-usm-cannula-screw-recall-2026","headline":"Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)","description":"On April 2, 2026, Intuitive Surgical initiated a Class 2 recall (FDA Z-2046-2026) of da Vinci X and Xi Surgical System Universal Surgical Manipulators (USMs) because screws within the arm sub-assembly may be susceptible to breaking. If all six screws break, the cannula mount can separate from the USM, potentially causing imprecise or unintended instrument tip motion during surgery. Intuitive sent Urgent Medical Device Correction letters to customers.","identifier":"8c7919af-a019-4ce8-9af5-954e718b9d42","datePublished":"2026-04-02T00:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","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":["primary-fda-database"]}}}