Facility

OMNICELL, INC.

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

Key facts

3recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011278888
Establishment type	Manufacture Medical Device
Location	51 Pennwood Place Warrendale, PA, US 15086
Registration status	Active · expires 2026
Parent company	Omnicell, Inc. (owner-operator 10059398)
Brand names	IVX Cloud; IVX Station; IVX Manager

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

System/Device, Pharmacy Compounding
Product code NEP (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

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

FDA inspections (2)

VAI2024-02-01
Voluntary Action Indicated · Compliance: Devices
NAI2018-02-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “OMNICELL, INC. (FEI 3011278888) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011278888-omnicell-inc/

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