Rolls of label stock used with the Omnicell i recalled over labeling errors

Recall date

March 25, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Omnicell, Inc. recalls Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (4…

Recall number

Z-2047-2026

FDA classification

Class I

Brand / firm

Omnicell, Inc.

Sold / distributed

US Distribution in Alabama, Maryland and Pennsylvania.

Why it was recalled

Potential for mislabeled syringe produced by the i.v.STATION device.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.