{"id":"3c523f25-07af-4809-a31c-c03c6cb2e163","slug":"auris-monarch-bronchoscope-leak-test-recall-2025","kind":"recall","headline":"Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results","summary":"Auris Health recalled Monarch bronchoscopes over out-of-range leak-test results indicating possible loss of fluid-ingress protection. The largest Monarch recall to date at 1,477 units. Source: FDA Class 2 device recall Z-0543-2026, accessdata.fda.gov / openFDA enforcement.","occurredAt":"2025-10-18T00:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":1477,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"createdAt":"2026-06-27T10:59:24.672Z","updatedAt":"2026-06-27T10:59:24.672Z","model":null,"deployment":null,"company":{"id":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","name":"Auris Health","slug":"auris-health","description":"Auris Health is an American medical robotics company based in Redwood City, California, a subsidiary of Johnson & Johnson MedTech. Its [Monarch Platform](/models/monarch-platform) is the first robotically assisted bronchoscopy system, providing minimally invasive access to and visualization of airways for diagnostic and therapeutic procedures.","status":"acquired by Johnson & Johnson (2019)","founded":null,"hq":"Redwood City, CA, USA","fundingTotal":null,"type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://techcrunch.com/2019/02/13/jj-spends-3-4-billion-in-cash-for-auris-healths-lung-cancer-diagnostics-and-surgical-robots/","title":"J&J acquires Auris Health for $3.4B","date_accessed":"2026-06-23"}],"keyFacts":[{"label":"Robot","value":"Monarch endoluminal platform for bronchoscopy"},{"label":"Focus","value":"Surgical robotics"},{"label":"Backers","value":"Acquired by Johnson & Johnson for $3.4B in 2019"},{"label":"Country","value":"US"},{"label":"HQ","value":"Redwood City, CA"},{"label":"Parent company","value":"Johnson & Johnson MedTech (acquired 2019 for $3.4B)"},{"label":"Product","value":"Monarch Platform robotic bronchoscopy system"},{"label":"Regulatory","value":"FDA cleared for diagnostic and therapeutic bronchoscopic procedures"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-24T01:51:54.280Z","updatedAt":"2026-07-03T22:57:11.967Z"},"derived":{"status":"active"},"sources":[],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/auris-monarch-bronchoscope-leak-test-recall-2025","url":"https://registry.deploy.report/incidents/auris-monarch-bronchoscope-leak-test-recall-2025","headline":"Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results","description":"Auris Health recalled Monarch bronchoscopes over out-of-range leak-test results indicating possible loss of fluid-ingress protection. The largest Monarch recall to date at 1,477 units. Source: FDA Class 2 device recall Z-0543-2026, accessdata.fda.gov / openFDA enforcement.","identifier":"3c523f25-07af-4809-a31c-c03c6cb2e163","datePublished":"2025-10-18T00:00:00.000Z","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":0,"primary_source_types":[]}}}