Recall Z-2047-2026 ยท NEP System/Device, Pharmacy Compounding
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, 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 ide
| Date | May 13, 2026 (initiated Mar 25, 2026) |
| Status | Open, Classified |
| Reason | Potential for mislabeled syringe produced by the i.v.STATION device. |
| Root cause | Process control |
| Action | Omnicell initially notified consignees on about 03/25/2026 via email and internal communication methods to IVCS technicians (Omnicell personnel operating within the hospitals). The communication provided instruction to cease use of new syringe label rolls, any affected units on hand should be segregated and clearly labeled "Do Not Use" until further notice, and to use the old syringe label rolls with the yellow backing. A formal notification was sent on about 04/13/2026. Consignees were instructed that onsite IV Compounding Service Resident Robotic Experts (IVCS RRE(s)) have segregated the i |
| Quantity | 220 units |
| Distribution | US Distribution in Alabama, Maryland and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.