{"url_path":"/fda/device/recalls/Z-2047-2026","section_key":"summary","section_title":"DEVICE Recall: Omnicell, Inc. — Rolls of label stock used with the Omnicell i.v.Station.      1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).      2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM).    Model/Catalog Number: IVS-RBT-001.     i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies l…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-25","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Omnicell, Inc."},"word_count":118,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2047-2026\n\n**Recalling firm:** Omnicell, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-25\n**Report date:** 2026-05-20\n\n## Product\nRolls of label stock used with the Omnicell i.v.Station.      1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).      2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM).    Model/Catalog Number: IVS-RBT-001.     i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.\n\n## Reason\nPotential for mislabeled syringe produced by the i.v.STATION device.\n\n## Affected lots\n1. Part Number 258920028, Lot Number: QN 200023473.   2. Part Number 258900029, Lot Number: QN 200023474.\n\n## Distribution\nUS Distribution in Alabama, Maryland and Pennsylvania."}