Class 1 Device Recall i.v.STATION pharmacy compounding device label stock

• Date Initiated by Firm: March 25, 2026
• Date Posted: May 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2047-2026
• Recall Event ID: 98717
• Product Classification: System/device, pharmacy compounding - Product Code NEP
• 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.
• Code Information: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
• FEI Number: 3007880912
• Recalling Firm/ Manufacturer: Omnicell, Inc.; 500 Cranberry Woods Dr Ste 400; Cranberry Township PA 16066-5224
• For Additional Information Contact: 724-741-7700
• Manufacturer Reason for Recall: Potential for mislabeled syringe produced by the i.v.STATION device.
• FDA Determined 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 impacted stock of the above-identified labels at each facility and have been instructed to return it to Omnicell. If any staff locate any labels with the affected part numbers/names listed in the Alert, please immediately segregate and do not use the label(s), and contact Omnicell Technical Support. Additionally, Omnicell requested that consignees continue to engage in vigilant pharmacist verification practices to verify the accuracy of labels, continue to use previously ordered non-sterile syringe labels, share this information with all those who need to be aware within each organization, and complete and return the Customer Acknowledgment form. Omnicell has taken the following immediate containment actions in relation to this Alert: (1) directed the segregation and discontinuation of use of impacted sterile label stock at each facility; (2) directed resuming use of previously ordered non-sterile syringe labels; and (3) quarantined impacted sterile label stock at Omnicell s manufacturing facility. All immediate containment activities have been completed. Impacted sterile label stock at each facility will be returned to Omnicell by IVCS RRE(s). Any additional corrective or preventative actions will be identified and implemented per Omnicell s standard processes, based on the results of our on-going engineering investigation.
• Quantity in Commerce: 220 units
• Distribution: US Distribution in Alabama, Maryland and Pennsylvania.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.