IVX Station Reconstitution Transfer Set — Class II medical device recall Z-1532-2025
Ongoing recall by Omnicell, Inc., reported 2025-04-16, distributed in AL. IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended f
| Recall number | Z-1532-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnicell, Inc., Cranberry Township, PA, United States |
| Recall initiated | 2025-02-20 |
| Classified | 2025-04-04 |
| Reported by FDA | 2025-04-16 |
| Distributed | AL |
| Quantity | 3 |
| Reason classes | sterility |
| Lot numbers | 011243 |
| Model numbers | 298921215 |
Product
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 the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
Reason for recall
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.
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-1532-2025. 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.