FDA recall Z-2047-2026

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2047-2026