Official recall notice

FDA DeviceClass INotable

Rolls of label stock used Recall (May 2026)

Product: 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.

Recall date
2026-05-20
FDA class
Class I

Why it was recalled

Hazard

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

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Product description

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

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