FDA Device recall Z-2047-2026
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part N…
- FDA Device
- Class I
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class I recall of Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part N… by Omnicell, citing potential for mislabeled syringe produced by the i.v.STATION device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2047-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-25 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Omnicell |
| Distribution | AL, MD, PA |
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
Potential for mislabeled syringe produced by the i.v.STATION device.
Identifiers
| code_info | 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2026%22
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