Rolls of label stock used with the Omnicell i — Class I medical device recall Z-2047-2026
Ongoing recall by Omnicell, Inc., reported 2026-05-20, distributed in AL, MD, PA. Potential for mislabeled syringe produced by the i.v.STATION device.
| Recall number | Z-2047-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnicell, Inc., Cranberry Township, PA, United States |
| Recall initiated | 2026-03-25 |
| Classified | 2026-05-13 |
| Reported by FDA | 2026-05-20 |
| Distributed | AL, MD, PA |
| Quantity | 220 units |
| Reason classes | labeling |
| Lot numbers | 200023473, 200023474 |
| Model numbers | 258900029, 258920028, IVS-RBT-001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2047-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.