Omnicell IVX Station medical device recalled for dose accuracy failures
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm medical device with potential for incorrect pharmaceutical dosing. However, no illnesses or injuries have been reported, limiting the score to 3 per the rubric: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The Omnicell IVX Station is an automated system used in healthcare settings to prepare pharmaceutical admixtures and syringes. OmniCell, Inc. is recalling six affected units with model number 298921373 and serial numbers IVXS000014 through IVXS000019. These units were distributed to locations in Alabama and New York.
The recall was issued because the IVX Station does not account for inherent scale inaccuracy or variability in its internal measurements. As a result, the device may pass preparations as acceptable and permit them to be dispensed even when the actual dose accuracy falls outside the limits specified in the product's labeling.
Healthcare facilities using these specific units should immediately stop using the affected devices and contact OmniCell, Inc. for guidance on remediation or replacement. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
- Manufacturer
- OmniCell, Inc.
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00860006285005 Serial Numbers: IVXS000014
- IVXS000015
- IVXS000016
- IVXS000017
- IVXS000018. IVXS000019
Distribution
Related recalls
Same manufacturer · OmniCell, Inc.
See all →- SevereOmnicell i.v.Station label stock rolls for syringe preparation
FDA (Devices) · 2026-05-20
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
Same hazard · dose inaccuracy
See all →- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
Similar recalls
- SevereOmnicell i.v.Station label stock rolls for syringe preparation
FDA (Devices) · 2026-05-20
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
- HighHealth Robotics Recalls i.v. Station Systems Due to Bag Mislabeling
FDA (Devices) · 2017-01-18
- HighIvenix Infusion System Devices Recalled for Alarm Sequencing Defect
FDA (Devices) · 2022-07-20
- ModerateMetrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
FDA (Devices) · 2016-08-03
- HighICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
FDA (Devices) · 2016-04-20