Cranberry Township, PA, United States
Omnicell, Inc. recalls
3 recalls recorded since 2018, most recently on 25 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 25 March 2026
- Reason
- Potential for mislabeled syringe produced by the i.v.STATION device.
- Distribution
- US Distribution in Alabama, Maryland and Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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). Mode
Ongoing Class II Medical devices
- Recall started
- 20 February 2025
- Reason
- IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
- Distribution
- Distributed in the US to Alabama
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1532-2025
- IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for
Ongoing Class II Medical devices
- Recall started
- 27 March 2023
- Reason
- IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
- Distribution
- AL, NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1617-2023
- Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.