Omnicell, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1532-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 20, 2025

Date Posted: April 16, 2025

Recall Number: Z-1532-2025

Event ID: 96422

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.

Status: Ongoing

Product Quantity: 3

Code Information:

Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.

Distribution Pattern:

Distributed in the US to Alabama

Voluntary or Mandated:

Voluntary: Firm initiated