Omnicell, Inc.
FDA Regulatory Profile
Omnicell, Inc. appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2047-2026, Class I) was initiated on March 25, 2026. Its most recent 510(k) clearance was granted on April 24, 2022.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2047-2026 | Class I | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERI | March 25, 2026 |
| Z-1532-2025 | Class II | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek P | February 20, 2025 |
| Z-1617-2023 | Class II | Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes | March 27, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212530 | IVX Fluid Transfer Set | April 24, 2022 |