BEUDAMED
    FDA Enforcement Class I Ongoing

    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.

    Recall: Z-2047-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2047-2026
    Event ID
    98717
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Omnicell, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 20, 2026
    Initiation Date
    March 25, 2026
    Classification Date
    May 13, 2026
    Address
    500 Cranberry Woods Dr Ste 400, Cranberry Township, PA, 16066-5224, United States

    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

    Potential for mislabeled syringe produced by the i.v.STATION device.

    Code Info

    1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.

    Distribution

    US Distribution in Alabama, Maryland and Pennsylvania.

    Quantity

    220 units