Omnicell IVX Station-For use in the automated preparation… recallZ-1617-2023 · OmniCell, Inc. · initiated Mar 27, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from OmniCell, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Omincell notified Customers via phone on 3/27/2023 and by Urgent Field Action: Mandatory Correction Of Product Labeling Ivx Station (Limited Release) Letter on 3/31/2023 via email. Letter states reason for recall, health risk and action to take: We will analyze specific devices at your Limited Release sites. Upon completion of our analysis updated labeling will be provided and will include the revised dose accuracy range.

Recall details

Recall number: Z-1617-2023
Status: Open, Classified
Initiated by the company: Mar 27, 2023
Posted by the FDA: May 22, 2023
Recalling firm: OmniCell, Inc.
Quantity: 6 units
Product code: NEP
Distribution: AL, NY

Product description

Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373

Code information (models, lots, serial numbers)

UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

IVX Station
Omnicell, Inc. · System/Device, Pharmacy Compounding
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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