{"id":"19ebb31c-6dce-4fe0-90eb-f98cb3a8d8bf","slug":"recall-2020-02-24-butterfly-network","kind":"recall","headline":"FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance","summary":"Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.","occurredAt":"2020-02-24T12:00:00.000Z","reviewStatus":"unreviewed","modelId":"b2d13502-17cd-4a08-a041-1975cd143852","deploymentId":null,"companyId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","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":"2026-07-03T17:05:59.299Z","updatedAt":"2026-07-03T17:05:59.299Z","model":{"id":"b2d13502-17cd-4a08-a041-1975cd143852","companyId":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","modelName":"Butterfly AI Ultrasound","slug":"butterfly-ai-ultrasound","description":"","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/","title":"Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool","sourceName":"Reuters"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[],"createdAt":"2026-07-03T16:14:15.301Z","updatedAt":"2026-07-03T17:06:46.826Z"},"deployment":null,"company":{"id":"10c41dfa-9a1d-4e6a-a63a-901375715bd7","name":"Butterfly Network","slug":"butterfly-network","description":"Butterfly Network develops AI-powered handheld ultrasound technology, including the [Butterfly iQ+](/models/butterfly-ai-ultrasound) and Butterfly iQ3 probes that enable whole-body imaging from a single semiconductor-based device. Founded in 2011 by Dr. Jonathan Rothberg, the company went public via a $1.5B SPAC merger with Longview Acquisition Corp. in February 2021 and trades on NYSE under BFLY. The company has received multiple FDA clearances for AI-powered ultrasound tools and deploys across health systems including [Atrium Health](https://atriumhealth.org) and Hennepin EMS.","status":null,"founded":2011,"hq":"Burlington, MA, USA","fundingTotal":"1030000000","type":"hardware","reviewStatus":"reviewed","sources":[{"url":"https://www.reuters.com/business/healthcare-pharmaceuticals/butterfly-network-gets-fda-clearance-ai-ultrasound-pregnancy-tool-2026-03-30/","title":"Butterfly Network gets FDA clearance for AI ultrasound pregnancy tool","sourceName":"Reuters"}],"keyFacts":[{"label":"CEO","value":"Joseph M. DeVivo"},{"label":"Founder","value":"Dr. Jonathan Rothberg"},{"label":"Stock","value":"NYSE: BFLY"},{"label":"Revenue 2025","value":"97.6M USD (company-reported)"},{"label":"Technology","value":"Ultrasound-on-Chip semiconductor"},{"label":"Ticker","value":"BFLY (NYSE)"},{"label":"SPAC merger date","value":"2021-02-16 (Longview Acquisition Corp, $1.5B valuation)"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-03T16:14:15.145Z","updatedAt":"2026-07-03T17:06:46.751Z"},"derived":{"status":"active"},"sources":[{"id":"1d9707be-fc96-41fa-b01e-022d666cf247","incidentId":"19ebb31c-6dce-4fe0-90eb-f98cb3a8d8bf","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=180229","label":null,"publishedAt":null,"notes":null,"title":"Class 2 Device Recall Butterfly iQ","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T17:05:59.457Z","updatedAt":"2026-07-03T17:05:59.457Z"}],"responses":[],"statusEvents":[{"id":"e05f9db6-5207-45be-b2ac-beec51ba5821","incidentId":"19ebb31c-6dce-4fe0-90eb-f98cb3a8d8bf","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T17:05:59.609Z","createdAt":"2026-07-03T17:05:59.610Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/recall-2020-02-24-butterfly-network","url":"https://registry.deploy.report/incidents/recall-2020-02-24-butterfly-network","headline":"FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance","description":"Butterfly Network issued a correction notification after distributing the Auto Bladder Volume Tool without an approved 510(k). The action affected 15,121 host devices in US distribution. Butterfly disabled the tool via software update and removed marketing references.","identifier":"19ebb31c-6dce-4fe0-90eb-f98cb3a8d8bf","datePublished":"2020-02-24T12:00:00.000Z","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":["primary-fda-database"]}}}