Omnicell, Inc.

Trieste, IT

OMNICELL, INC. appears in FDA device records in Trieste, IT. FDA records list one 510(k) clearance, no PMA records and 4 registered establishments. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 4
Registered establishments: 4

FDA records under these names

1 name

FDA records resolved to Omnicell, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

HEALTH ROBOTICS S.R.L.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Omnicell, Inc. in 2022.

Clearances by year, as a table

510(k) clearance decisions for Omnicell, Inc., by decision year
Year	Clearances
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K212530	IVX Fluid Transfer Set	LHI	Substantially Equivalent	2022-04-24

Registered establishments

FDA registered establishments for Omnicell, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007880912	3007880912	OMNICELL, INC.	500 Cranberry Woods Dr., Cranberry Township, PA 16066 US	2026	BRY LHI NEP
3011278888	3011278888	OMNICELL, INC.	51 Pennwood Place, Warrendale, PA 15086 US	2026	NEP
3015426639	3015426639	OMNICELL, INC.	725 Sycamore Drive, Milpitas, CA 95035 US	2026	BRY
3006153342	3006153342	Omnicell S.R.L.	Piazzale Legnami 1/b Edificio 9 Comprensorio Gaslini, TRIESTE 34145 IT	2026	NEP

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2047-2026	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.	Potential for mislabeled syringe produced by the i.v.STATION device.	Class I	2026-03-25	Open, Classified
Z-1532-2025	IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.	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.	Class II	2025-02-20	Open, Classified
Z-1617-2023	Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373	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 II	2023-03-27	Open, Classified
Z-0989-2017	i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448	The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.	Class II	2016-11-23	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain