CLASS I ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Rolls of label stock used with the Omnicell i.v.Station recalled
Omnicell is recalling Rolls of label stock used with the Omnicell i.v.Station, distributed in Alabama, Maryland, Pennsylvania. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2047-2026
- FDA event ID
- 98717
- Recalling firm
- Omnicell, Cranberry Township, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 13 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 13 May 2026 | Classified by FDA | +49 days |
| 20 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for mislabeled syringe produced by the i.v.STATION device.
Product as listed by the FDA
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.
Where it was distributed
US Distribution in Alabama, Maryland and Pennsylvania.
Questions about this recall
Why was it recalled?
Potential for mislabeled syringe produced by the i.v.STATION device.
Which lots are affected?
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Where was it sold?
US Distribution in Alabama, Maryland and Pennsylvania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Omnicell
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IVX Station Reconstitution Transfer Set recalled by Omnicell | Omnicell | Sterility | AL |
| Device | CLASS II | IVX Station-For use in the automated preparation recalled by OmniCell | OmniCell | Device Malfunction | AL, NY |
Other Syringes & Needles recalls
All 1,066| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Embosphere 500-700 micrometer Syringe Sterile Steam recalled | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |