FDAHealthMarch 25, 2026
Omnicell, Inc. — 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, I
⚠️ Potential for mislabeled syringe produced by the i.v.STATION device.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- March 25, 2026
US Distribution in Alabama, Maryland and Pennsylvania.
What's affected?
- 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.
- Brand
- Omnicell, Inc.
- Lot code
- QN
Additional details
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 220 units.
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