Omnicell, Inc. FDA Recalls

3 recalls on file across devices, 1 of them Class I and 3 still open. Matched by name to OMCL.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGClass IMar 25, 2026Potential for mislabeled syringe produced by the i.v.STATION	Potential for mislabeled syringe produced by the i.v.STATION device.	Class IDevices	Mar 25, 2026
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek PoucheClass IIFeb 20, 2025IVX Station Reconstitution Transfer Sets were shipped in adv	IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended f	Class IIDevices	Feb 20, 2025
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 29892Class IIMar 27, 2023IVX Station does not account for inherent scale inaccuracy o	IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being	Class IIDevices	Mar 27, 2023