Omnicell, Inc.: System/device, Pharmacy Compounding
Recall Summary Omnicell is recalling label stock rolls used in its i.v.Station device, which automatically prepares and labels IV medications in pharmacies. The labels may not apply correctly to syringes, potentially resulting in mislabeled medications. This recall affects facilities in Alabama, Maryland, and Pennsylvania.
- Recalling firm
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-25
- Status
- Open, Classified
- Distribution
- US Distribution in Alabama, Maryland and Pennsylvania.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5d71c489-f044-45f5-8319-07312a5f0e3b