FDA Medical devices recall ·
Rolls of label stock used with the Omnicell i.v.Station recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2047-2026
- Date
- (initiated March 25, 2026)
- Company / brand
- Omnicell, Inc.
500 Cranberry Woods Dr Ste 400, Cranberry Township, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 220 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for mislabeled syringe produced by the i.v.STATION device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Distribution
US Distribution in Alabama, Maryland and Pennsylvania.
States: Alabama Maryland Pennsylvania
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2047-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.