Omnicell IVX Station-For use in the automated preparation of… — Class II medical device recall Z-1617-2023
Ongoing recall by OmniCell, Inc., reported 2023-05-31, distributed in AL, NY. IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being
| Recall number | Z-1617-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OmniCell, Inc., Warrendale, PA, United States |
| Recall initiated | 2023-03-27 |
| Classified | 2023-05-22 |
| Reported by FDA | 2023-05-31 |
| Distributed | AL, NY |
| Quantity | 6 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00860006285005 |
| Serial numbers | IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018, IVXS000019 |
| Model numbers | 298921373 |
Product
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1617-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.