Omnicell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1532-2025Class IIIVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek PFebruary 20, 2025
Z-1617-2023Class IIOmnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes March 27, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K212530IVX Fluid Transfer SetApril 24, 2022