Chrysalis Intelligence · Sponsors · Omnicell, Inc.

Omnicell, Inc.

Cranberry, PA, US · 1 510(k) clearances · 3 recalls (1 Class I)

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Total clearances

1

2022-04-24 → 2022-04-24

Last 12 months

0

Product codes

1

Most recent

2022-04-24

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LHI	Set, I.V. Fluid Transfer	Class II	General Hospital	1	2022-04-24

Safety

Recalls (3)

Class I (serious)

1

Risk of injury / death

Total recalls

3

Currently ongoing

3

Most recent

2026-03-25

Date	Severity	Status	Recall #	Product	Code	Reason
2026-03-25	Class I	Ongoing	Z-2047-2026	Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRING…	—	Potential for mislabeled syringe produced by the i.v.STATION device.
2025-02-20	Class II	Ongoing	Z-1532-2025	IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche…	—	IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intend…
2023-03-27	Class II	Ongoing	Z-1617-2023	Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 29892…	—	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 state…

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2022-04-24	K212530	IVX Fluid Transfer Set	LHI	Class II	General Hospital