Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRING
Summary
The FDA issued a Class I for Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258 by Omnicell, Inc.. Reason: Potential for mislabeled syringe produced by the i.v.STATION device..
Details
Source
Device Recall
External ID
Z-2047-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.
Quantity Affected: 220 units
Reason for Recall
Potential for mislabeled syringe produced by the i.v.STATION device.
Distribution
US Distribution in Alabama, Maryland and Pennsylvania.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Cranberry Township, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Omnicell, Inc. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Omnicell, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Omnicell, Inc. have FDA actions?
Omnicell, Inc. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2047-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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