# FDA recall Z-2047-2026

> **Omnicell, Inc.** · Class I · device recall initiated 2026-03-25.

## Product

Rolls of label stock used with the Omnicell i.v.Station.      1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).      2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM).    Model/Catalog Number: IVS-RBT-001.     i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

## Reason for recall

Potential for mislabeled syringe produced by the i.v.STATION device.

## Distribution

US Distribution in Alabama, Maryland and Pennsylvania.

## Key facts

- **Recall number:** Z-2047-2026
- **Recalling firm:** Omnicell, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-25
- **Report date:** 2026-05-20

- **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-2047-2026

## Citation

> MORVS. FDA recall Z-2047-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/Z-2047-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*