Recall Z-2047-2026— Omnicell, Inc.
Class I · Ongoing
Class I FDA medical device recall by Omnicell, Inc., initiated 2026-03-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 labels to compounded preparations for identification and traceability.. Reason: Potential for mislabeled syringe produced by the i.v.STATION device..
- Recalling firm
- Omnicell, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Cranberry Township, PA, United States
Product description
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 labels to compounded preparations for identification and traceability.
Reason for recall
Potential for mislabeled syringe produced by the i.v.STATION device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.