← FDA ENFORCEMENT
Z-2047-2026Class I

Omnicell, Inc.

Recalling firm
Omnicell, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US Distribution in Alabama, Maryland and Pennsylvania.
Firm state
PA
Product quantity
220 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

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.

Code / lot info

1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.