Is this your brand? Sign in to claim ownership.

Omnicell, Inc.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
XT Anesthesia Workstation (AWS)	XT-AWS	FDA UDI	Class I	Active
IVX Station Reconstitution Transfer Set	IVX Station Reconstitution Transfer Set	FDA UDI	Class II	Active
IVX Station	IVX Station	FDA UDI	Class II	Active
IVX Station Stock Solution Transfer Set	IVX Station Stock Solution Transfer Set	FDA UDI	Class II	Active
IVX Cloud	IVX Cloud	FDA UDI	Class II	Unknown
IVX Manager	IVX Manager	FDA UDI	Class II	Active
IVX Cloud	IVX Cloud	FDA UDI	Class II	Active
IVX Fluid Transfer Set	K212530	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 25, 2026	Z-2047-2026	—	open, classified	Potential for mislabeled syringe produced by the i.v.STATION device.
Feb 20, 2025	Z-1532-2025	—	open, classified	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 sterility cannot be ensured.
Mar 27, 2023	Z-1617-2023	—	open, classified	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