{"id":"268ee279-2055-4d62-b8f9-2bd864d54d76","slug":"omnicell-ivstation-syringe-label-recall-2026","kind":"recall","headline":"FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations","summary":"On May 21, 2026, the FDA classified as a Class I recall Omnicell's removal of certain syringe labels used with the i.v.STATION automated compounding system. Inconsistent label detection behavior across i.v.STATION printers could result in unlabeled or mislabeled sterile syringe preparations after compounding. No serious injuries or deaths were reported as of April 2026.","occurredAt":"2026-04-10T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"4b4def26-5306-4c0c-a4a8-a3672c7faf56","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":null,"rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":null,"regulatoryBody":null,"propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"createdAt":"2026-07-14T05:07:01.947Z","updatedAt":"2026-07-14T21:53:38.800Z","model":null,"deployment":null,"company":{"id":"4b4def26-5306-4c0c-a4a8-a3672c7faf56","name":"Omnicell","slug":"omnicell","description":"Omnicell, Inc. (NASDAQ: OMCL) is an American healthcare technology company specializing in medication management automation. Founded in 1992 by Randall Lipps and headquartered in Cranberry Township, Pennsylvania, Omnicell provides the [XR2 Automated Central Pharmacy System](/models/omnicell-xr2), automated dispensing cabinets, and IV compounding robots to hospitals and health systems. The company reported $1.185 billion in revenue for fiscal year 2025 and serves thousands of hospitals and pharmacies across North America.","status":"active","founded":1992,"hq":"Cranberry Township, Pennsylvania, USA","fundingTotal":null,"type":"hardware","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.omnicell.com/central-pharmacy/xr2/","title":"Omnicell XR2 pharmacy robot"},{"url":"https://www.omnicell.com/","label":"Omnicell — Official Website","title":"Omnicell — Official Website","mediaType":"article","sourceName":"Omnicell (official)"},{"url":"https://ir.omnicell.com/news/news-details/2026/Omnicell-Announces-Fiscal-Year-and-Fourth-Quarter-2025-Financial-Results/default.aspx","label":"Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results","title":"Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results","mediaType":"article","sourceName":"Omnicell IR"}],"keyFacts":[{"label":"Ticker","value":"NASDAQ: OMCL"},{"label":"Revenue","value":"1.185 billion USD FY2025"},{"label":"Clients","value":"Thousands of hospitals and pharmacies across North America"},{"label":"Product portfolio","value":"XR2 Central Pharmacy System, automated dispensing cabinets, i.v.STATION, Medimat"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"createdAt":"2026-06-24T04:35:20.917Z","updatedAt":"2026-07-14T05:06:41.091Z"},"derived":{"status":"active"},"sources":[{"id":"aa2b4e8b-a1be-451e-b628-992542e5b224","incidentId":"268ee279-2055-4d62-b8f9-2bd864d54d76","url":"https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/automated-compounding-system-recall-omnicell-removes-syringe-labels-used-ivstation-automated","label":"FDA Class I Recall: Omnicell i.v.STATION Syringe Labels","publishedAt":"2026-05-21T00:00:00.000Z","notes":null,"title":"FDA Class I Recall: Omnicell i.v.STATION Syringe Labels","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-14T05:07:02.739Z","updatedAt":"2026-07-14T05:07:02.739Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/omnicell-ivstation-syringe-label-recall-2026","url":"https://registry.deploy.report/incidents/omnicell-ivstation-syringe-label-recall-2026","headline":"FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations","description":"On May 21, 2026, the FDA classified as a Class I recall Omnicell's removal of certain syringe labels used with the i.v.STATION automated compounding system. Inconsistent label detection behavior across i.v.STATION printers could result in unlabeled or mislabeled sterile syringe preparations after compounding. No serious injuries or deaths were reported as of April 2026.","identifier":"268ee279-2055-4d62-b8f9-2bd864d54d76","datePublished":"2026-04-10T00:00:00.000Z","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"]}}}