Medical DeviceMay 20, 2026
Omnicell Rolls of label stock used with the Omnicell i.v.Station. 1 recall — FDA Z-2047-2026
Potential for mislabeled syringe produced by the i.v.STATION device.
Class IFDA: OngoingOmnicell, Inc.
Recall history in this database
Classification mix: Class II: 2, Class I: 1.
Medical DeviceApr 16, 2025
Omnicell IVX Station Reconstitution Transfer Set recall — FDA Z-1532-2025
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and…
Class IIFDA: OngoingOmnicell, Inc.
Medical DeviceMay 31, 2023
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and recall — FDA Z-1617-2023
IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
Class IIFDA: OngoingOmniCell, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Omnicell, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.