Omnicell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2047-2026Class IRolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERIMarch 25, 2026
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