{"id":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","slug":"auris-monarch-aspirating-biopsy-needle-breakage-recall-2020","kind":"recall","headline":"Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage","summary":"Auris Health recalled the Monarch Aspirating Biopsy Needle (REF MBR-000012) after reports of needle breakage. 158 units. Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.","occurredAt":"2019-04-19T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"serious","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":158,"affectedUnitsBasis":"exact","remediationStatus":null,"regulatoryAction":"recall_ordered","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":2,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-06-27T11:10:33.691Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","name":"Auris Health","slug":"auris-health","description":"American surgical robotics company developing the Monarch Platform for robotic-assisted bronchoscopy. Founded by Frederic Moll (also founder of Intuitive Surgical). 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Source: FDA Class 2 device recall Z-0025-2020, openFDA enforcement / accessdata.fda.gov.","identifier":"c1f9d75c-99c1-483e-ae90-b58ba27f1bad","datePublished":"2019-04-19T00:00:00.000Z","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"]}}}