RegWardenFDA facility compliance records
Company

Omnicell, Inc.

3 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2023: 1 recalls; 2025: 1 recalls; 2026: 1 recalls2017201820192020202120221202320241202512026
  • Recalls (3)

Registered facilities (3)

Recalls & enforcement

  • Class IOngoing2026-03-25
    Potential for mislabeled syringe produced by the i.v.STATION device.
  • Class IIOngoing2025-02-20
    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 system calibration. The items were not shipped in a validated packing configuration and st…
  • Class IIOngoing2023-03-27
    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

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Omnicell, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10059398-omnicell-inc/

Not open yet

Alerts for Omnicell, Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.