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CLASS I · SeriousFDA

Omnicell, Inc. recalls Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028

📅 Mar 25, 2026 · 📍 AL, MD, PA
Recalling company
Omnicell, Inc.
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.
Reason
Potential for mislabeled syringe produced by the i.v.STATION device.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Mar 25, 2026
Reported
May 20, 2026
Distribution
US Distribution in Alabama, Maryland and Pennsylvania.
Status
Ongoing
Quantity
220 units
Lot / codes
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Company location
Cranberry Township, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-2047-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2047-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.