FDA recall, , High risk
Omnicell i.v.Station Syringe Labels
Rolls of label stock used with the Omnicell i.v.Station may cause mislabeled syringes.
Summary by Recall Canary from the FDA notice
What happened
Omnicell, Inc. of Cranberry Township, Pennsylvania, recalled rolls of label stock used with the Omnicell i.v.Station, an automation device for preparing and compounding IV medications that applies labels to compounded preparations. The recall, which began March 25, 2026, was added to the FDA's Enforcement Report on May 13, 2026. The potential for mislabeled syringes produced by the device prompted the action. The recall affects 220 units distributed in Alabama, Maryland, and Pennsylvania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Rolls of label stock used with the Omnicell i.v.Station
- Model number
- IVS-RBT-001
- UDI-DI
- 258920028
- 200023473
- 258900029
- 200023474
From the FDA notice
Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).
Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM).
Recall details
- Company began the recall
- Sold in
- Company
- Omnicell, Inc.Cranberry Township, Pennsylvania
- Hazard
- Labeling error
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98717
- Recall number
- Z-2047-2026
- Quantity recalled
- 220 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
