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
- Brand
- Omnicell, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Potential for mislabeled syringe produced by the i.v.STATION device.
Product description
Potential for mislabeled syringe produced by the i.v.STATION device.