FDAClass I · Medical device · Recalled May 20, 2026

Rolls of label stock used with the Omnicell i recall — Omnicell, Inc.

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

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2047-2026
Brand: Omnicell
Classification: Class I
Units affected: 220 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Rolls of label stock used with the Omnicell i

Companies & origin

Recalling firm location: Cranberry Township, PA, United States
Firm address: 500 Cranberry Woods Dr Ste 400, 16066-5224

Identifying details (verbatim from the notice)

Product codes / lots: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Distribution: US Distribution in Alabama, Maryland and Pennsylvania.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98717
Recall initiated: March 25, 2026
FDA classified: May 13, 2026
FDA report date: May 20, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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