Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028 recall (Omnicell, Inc.)
Medical deviceClass IOngoing
Summary: Omnicell, Inc. is recalling 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 . Reason: Potential for mislabeled syringe produced by the i.v.STATION device.
What is being recalled
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.
Why
Potential for mislabeled syringe produced by the i.v.STATION device.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
US Distribution in Alabama, Maryland and Pennsylvania. (states named: Alabama, Maryland, Pennsylvania)
How to tell if yours is affected
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2047-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | March 25, 2026 |
| Reported | May 20, 2026 |
| Company | Omnicell, Inc. |
| Company location | Cranberry Township, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 220 units |
More recalls from Omnicell, Inc. · all medical device recalls · recalls from March 2026