# FDA recall Z-1532-2025

> **Omnicell, Inc.** · Class II · device recall initiated 2025-02-20.

## 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.

## Distribution

Distributed in the US to Alabama

## Key facts

- **Recall number:** Z-1532-2025
- **Recalling firm:** Omnicell, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-20
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cranberry Township, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1532-2025

## Citation

> AI Analytics. FDA recall Z-1532-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1532-2025. Source: US FDA. Licensed CC0.

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