Food, drugs, devices › Omnicell, Inc.
Device recall: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40
FDA enforcement event 98717 is a device recall by Omnicell, Inc. of Cranberry Township, PA, initiated 25 Mar 2026 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 12% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Omnicell, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Omnicell, Inc., Cranberry Township, PA.
Reason for recall
"Potential for mislabeled syringe produced by the i.v.STATION device."
Distribution
"US Distribution in Alabama, Maryland and Pennsylvania."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2047-2026 | 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… | 220 units | Class I | Ongoing | 20 May 2026 |
Context
Other enforcement events for Omnicell, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2025 | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche | Device | Class II | 1 |
| 27 Mar 2023 | Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921 | Device | Class II | 1 |
All 3 events for Omnicell, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential for mislabeled syringe produced by the i.v.STATION device."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution in Alabama, Maryland and Pennsylvania."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.