Omnicell, Inc.
United Statesfrom the FDA registration address FDA FEI 3007880912
Omnicell, Inc. is a medical device manufacturer, with 8 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 3 FDA recalls as of 14 Nov 2026.
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 33 ongoing
Registry facts
- Registries
- FDA GUDID 7
- FDA 510(k) 1
- Device classes
- FDA Class II 7
- FDA Class I 1
- FDA recalls
- Identifiers
- FDA FEI 3007880912
- DUNS 080720061
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
IVX Fluid Transfer Set Ref K212530
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007880912
- DUNS number
- 080720061
- Address
- 500 Cranberry Woods Dr., Cranberry Township, PA, 16066
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 1
- 2026 1
2026
- 25 Mar 2026 Z-2047-2026 Class I Ongoing Potential for mislabeled syringe produced by the i.v.STATION device.
2025
- 20 Feb 2025 Z-1532-2025 Class II Ongoing 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.
2023
- 27 Mar 2023 Z-1617-2023 Class II Ongoing 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
Frequently asked questions
How many devices does Omnicell, Inc. have in the registry?
The registry currently lists 8 devices for Omnicell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnicell, Inc.'s devices?
Among its 8 most recently registered devices, Omnicell, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Omnicell, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Omnicell, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Omnicell, Inc.?
FDA recall records list 3 recalls initiated by Omnicell, Inc., the most recent initiated on 25 Mar 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Omnicell, Inc. in the registry?
The most recently registered devices listed for Omnicell, Inc. include XT Anesthesia Workstation (AWS) XT-AWS, IVX Station Reconstitution Transfer Set, IVX Station and IVX Station Stock Solution Transfer Set.